Financial Data and Key Metrics Changes - The consolidated revenues for Q1 FY26 were $997 million, reflecting an 11% year-over-year growth and remaining flat sequentially [7] - EBITDA margin was reported at 26.7%, slightly above the target of 25% [6] - The net profit after tax attributable to equity holders was $166 million, a 2% increase year-over-year but an 11% decline sequentially [11] - Operating working capital increased to $1.55 billion, up by $84 million from the previous quarter [12] Business Line Data and Key Metrics Changes - North American business revenue declined by 17% year-over-year to $400 million, primarily due to price erosion [21] - European generic business revenue was $131 million, a 124% year-over-year increase, driven by new product launches [21] - Emerging market revenue grew by 10% year-over-year, with 26 new products launched [22] - The PSAI business reported revenue of $95 million, showing year-over-year growth but a 14% sequential decline [24] Market Data and Key Metrics Changes - The Indian market reported a revenue of INR 14.71 billion, with a year-over-year growth of 11% and a sequential increase [23] - The Russia business showed a 17% year-over-year growth, indicating resilience despite macroeconomic challenges [22] Company Strategy and Development Direction - The company is focused on optimizing structural costs and driving operational efficiencies while scaling its presence in consumer health, innovative therapies, and biosimilars [15] - Strategic collaborations are being pursued to enhance capabilities, particularly in biosimilars and complex generics [25] - The company aims to maintain a strong balance sheet with a net cash surplus of $341 million [17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged softness in the US generic market but expressed confidence in recovery through new product launches [16] - The company expects normalized effective tax rates to remain around 25% for the fiscal year [11] - Management highlighted the importance of upcoming product launches, particularly semaglutide, for future growth [40] Other Important Information - The company received a CDP rating of 'A' in the climate category, reflecting its commitment to sustainability [19] - The company is actively exploring strategic partnerships and acquisitions to diversify its portfolio [25] Q&A Session Summary Question: Performance of the US-based business - Management indicated that the US base business decreased, primarily due to timing issues, and expects flat to single-digit growth for FY26 [32] Question: Outlook for Revlimid - Management anticipates a similar trajectory for Revlimid in upcoming quarters, with a potential decline in Q3 [33] Question: Timeline for semaglutide launches - Management expects to launch semaglutide in Canada and other markets in calendar 2026, with a focus on capacity [40] Question: Gross margin trends - Management expects gross margins to remain stable for the year, with SG&A costs projected to be in the 28-29% range [45] Question: Cost-saving measures - Management indicated potential cost savings of 500 to 600 basis points, translating to significant savings, but emphasized that not all savings would be realized [63] Question: Update on biosimilar abatacept trials - Management confirmed that the readout for the phase two trial is expected on November 25, with plans to submit a BLA thereafter [60] Question: Capacity for semaglutide - Management expressed confidence in the ability to sell the planned 12 million pens, citing strong demand [72]

Financial Performance - Revenues reached ₹8,545 Cr, showing an 11% YoY growth[9] - EBITDA stood at ₹2,278 Cr with a margin of 26.7%[9] - Profit Before Tax (PBT) was ₹1,905 Cr, representing 22%[9] - Profit After Tax (PAT) amounted to ₹1,418 Cr, which is 17%[9] Segment Performance - Global Generics contributed ₹7,562 Cr, with a 10% YoY increase[13] - North America generated ₹3,412 Cr in revenue, up by 11% YoY[13] - India's revenue was ₹1,471 Cr, marking an 11% YoY growth[13] - Europe reported revenue of ₹1,274 Cr, a significant 142% YoY increase, including revenues from the acquired NRT business[13] - Pharmaceutical Services & Active Ingredients (PSAI) achieved ₹818 Cr in revenue, a 7% YoY increase[13] - Emerging Markets reached ₹1,404 Cr in revenue, showing an 18% YoY increase[13] Financial Position - Net Cash surplus at ₹2,922 Cr as of June 30, 2025[11, 22]

[Notice of 41st Annual General Meeting](index=1&type=section&id=Notice%20of%2041st%20Annual%20General%20Meeting) This notice details Dr. Reddy's Laboratories Ltd.'s 41st Annual General Meeting, covering agenda items, virtual participation instructions, dividend and taxation information, and key shareholder services [Meeting Details and Agenda](index=1&type=section&id=Meeting%20Details%20and%20Agenda) Dr. Reddy's Laboratories Ltd. announces its 41st Annual General Meeting (AGM) to be held virtually on Thursday, July 24, 2025, at 11:00 A.M. IST, covering ordinary and special business matters AGM Schedule | Event | Date and Time | | :--- | :--- | | **AGM Date and Time** | 11:00 a.m. IST, Thursday, July 24, 2025 | | **Cut-off date for e-voting** | Thursday, July 17, 2025 | | **E-voting start** | 9:00 a.m. IST, Sunday, July 20, 2025 | | **E-voting end** | 5:00 p.m. IST, Wednesday, July 23, 2025 | - The 41st AGM will be conducted entirely through Video Conferencing ('VC')/ Other Audio-Visual Means ('OAVM')[4](index=4&type=chunk) [Ordinary Business](index=2&type=section&id=Ordinary%20Business) The ordinary business includes adopting the Audited Financial Statements for FY2025, declaring a final dividend of **INR 8** per equity share, and re-appointing Mr. G V Prasad as a Director - To receive, consider and adopt the Audited Financial Statements (Standalone and Consolidated) for the financial year ended March 31, 2025[10](index=10&type=chunk) Proposed Dividend | Item | Details | | :--- | :--- | | Dividend per equity share | INR 8/- | - To re-appoint Mr. G V Prasad (DIN:00057433) as a Director, who retires by rotation and is eligible for re-appointment[10](index=10&type=chunk) [Special Business](index=2&type=section&id=Special%20Business) Special business items require shareholder approval for Mr. G V Prasad's re-appointment as Co-Chairman and Managing Director, ratification of Cost Auditors' remuneration for FY2026, and appointment of the Secretarial Auditor - Approval for the re-appointment of Mr. G V Prasad as Whole-time Director designated as Co-Chairman and Managing Director for five years, from January 30, 2026, to January 29, 2031[5](index=5&type=chunk) - Ratification of remuneration of **INR 900,000** plus taxes for M/s. Sagar & Associates, Cost Accountants, for the financial year ending March 31, 2026[12](index=12&type=chunk) - Approval for the appointment of M/s. Makarand M. Joshi & Co., Company Secretaries, as Secretarial Auditor for five consecutive financial years from April 1, 2025, to March 31, 2030[13](index=13&type=chunk) [Shareholder Information and Instructions](index=4&type=section&id=Shareholder%20Information%20and%20Instructions) This section provides comprehensive guidelines for shareholders regarding virtual AGM participation, dividend payment procedures, tax deduction at source (TDS) on dividends, and other statutory compliance matters [General Instructions for AGM](index=4&type=section&id=General%20Instructions%20for%20AGM) The virtual AGM attendance is limited to 1,000 members on a first-come, first-served basis, excluding major shareholders and company officials, with no proxy appointments available - The 41st AGM will be held through VC/OAVM in compliance with MCA and SEBI circulars, with the deemed venue being the Registered Office[16](index=16&type=chunk) - Virtual attendance is limited to **1,000 members** on a first-come, first-served basis, but this restriction does not apply to large shareholders (**2% or more**), Promoters, Directors, and Auditors[16](index=16&type=chunk) - The facility for appointing proxies by members will not be available for this virtual AGM[45](index=45&type=chunk) [Dividend and Taxation](index=5&type=section&id=Dividend%20and%20Taxation) A final dividend of **INR 8** per share for FY25 is recommended, payable by July 30, 2025, with applicable tax deduction at source (TDS) procedures detailed for resident and non-resident shareholders Dividend Details | Item | Details | | :--- | :--- | | **Recommended Final Dividend** | INR 8/- per equity share of face value INR 1/- each | | **Record Date** | July 10, 2025 | | **Payment Date** | On or before July 30, 2025 | TDS Rates for Resident Shareholders | Condition | TDS Rate | | :--- | :--- | | Valid PAN available | 10% | | No PAN / Invalid PAN | 20% | - Non-resident shareholders can avail benefits under a Double Tax Avoidance Treaty (DTAA) by providing a self-attested Tax Residency Certificate (TRC), PAN, and a self-declaration in Form 10F[23](index=23&type=chunk)[26](index=26&type=chunk) - No tax will be deducted for resident individuals if the total dividend for FY 2025-26 does not exceed **INR 10,000**, or if a valid Form 15G/15H is submitted[21](index=21&type=chunk) [Shareholder Services and Compliance](index=8&type=section&id=Shareholder%20Services%20and%20Compliance) Shareholders with physical shares must update KYC details for dividend eligibility, and information is provided on claiming unpaid dividends from the IEPF and using the new SEBI Online Dispute Resolution (ODR) Portal - Effective April 1, 2024, shareholders holding shares in physical mode must update their KYC details to be eligible to receive dividends[42](index=42&type=chunk) - Shares with dividends remaining unpaid for seven consecutive years will be transferred to the IEPF, from which shareholders can claim them from the IEPF Authority[42](index=42&type=chunk) - SEBI has established a common Online Dispute Resolution (ODR) Portal (https://smartodr.in/login) for resolving disputes in the Indian securities market[41](index=41&type=chunk)[44](index=44&type=chunk) [Explanatory Statement for Special Business](index=10&type=section&id=Explanatory%20Statement%20for%20Special%20Business) This section provides the board's rationale and detailed information for the special business items on the AGM agenda, including re-appointment and remuneration of the Co-Chairman & MD, Cost Auditors, and Secretarial Auditor [Re-appointment of Mr. G V Prasad (Co-Chairman and Managing Director)](index=10&type=section&id=Re-appointment%20of%20Mr.%20G%20V%20Prasad%20%28Co-Chairman%20and%20Managing%20Director%29) The board recommends Mr. G V Prasad's re-appointment as Co-Chairman and Managing Director for a five-year term (2026-2031) due to consistent growth under his leadership, proposing a revised remuneration package with approximately **85%** variable and performance-linked components - The re-appointment is recommended due to the company's sustained growth in revenues and profitability under Mr. Prasad's leadership[50](index=50&type=chunk) Comparison of Current and Proposed Remuneration for Mr. G V Prasad | Particulars | Current Terms | Proposed Terms | | :--- | :--- | :--- | | **Salary** | INR 1,200,000 per month | INR 1,440,000 per month (with up to 5% annual increase) | | **Housing Allowance** | INR 600,000 per month | INR 720,000 per month | | **Medical Reimbursement** | Up to INR 15,000 per annum | Up to one month's salary + medical insurance & health check-up | | **Leave Travel Assistance** | Up to INR 1,200,000 per annum | Up to INR 1,440,000 per annum | | **Commission** | Up to 0.75% of net profits | Up to 0.75% of net profits | - The company's executive compensation philosophy emphasizes variable, performance-linked components, with approximately **85%** of the total remuneration being variable[52](index=52&type=chunk) [Ratification of Remuneration for Cost Auditors](index=13&type=section&id=Ratification%20of%20Remuneration%20for%20Cost%20Auditors) Shareholder approval is sought to ratify the remuneration of **INR 900,000** plus applicable taxes and expenses for M/s. Sagar & Associates, re-appointed as Cost Auditors for the financial year ending March 31, 2026 Cost Auditor Remuneration | Auditor | Financial Year | Proposed Remuneration | | :--- | :--- | :--- | | M/s. Sagar & Associates | Ending March 31, 2026 | INR 900,000/- plus applicable taxes and expenses | [Appointment of Secretarial Auditor](index=13&type=section&id=Appointment%20of%20Secretarial%20Auditor) The board proposes appointing M/s. Makarand M. Joshi & Co. as Secretarial Auditors for a five-year term (2025-2030), with remuneration for FY2026 set at **INR 400,000** plus applicable taxes and expenses Secretarial Auditor Appointment and Remuneration | Auditor | Term | Remuneration for FY 2026 | | :--- | :--- | :--- | | M/s. Makarand M. Joshi & Co. | April 1, 2025 to March 31, 2030 | INR 400,000 plus applicable taxes and expenses | [Instructions for E-Voting and Virtual Meeting Participation](index=15&type=section&id=Instructions%20for%20E-Voting%20and%20Virtual%20Meeting%20Participation) This section provides detailed, step-by-step instructions for shareholders on how to participate in the AGM, outlining procedures for remote e-voting and joining/voting during the live virtual meeting [Remote E-Voting Procedure](index=15&type=section&id=Remote%20E-Voting%20Procedure) Shareholders can cast votes electronically via the NSDL e-voting platform from July 20-23, 2025, with distinct login instructions provided for individual demat account holders and other shareholders Remote E-Voting Schedule | Item | Details | | :--- | :--- | | **Platform** | NSDL e-Voting (www.evoting.nsdl.com) | | **Start Date & Time** | Sunday, July 20, 2025, at 9:00 a.m. (IST) | | **End Date & Time** | Wednesday, July 23, 2025, at 5:00 p.m. (IST) | | **Cut-off Date** | Thursday, July 17, 2025 | - Individual shareholders with demat accounts can vote through their depository's portal (NSDL or CDSL) using OTP-based or existing login credentials[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - Shareholders holding shares in physical form or non-individual shareholders must use their Folio Number or DP ID/Client ID to log in to the NSDL e-voting website[82](index=82&type=chunk) [Virtual Meeting (VC/OAVM) Participation](index=18&type=section&id=Virtual%20Meeting%20%28VC%2FOAVM%29%20Participation) Shareholders can attend the live AGM via the NSDL e-voting portal, with a stable internet connection recommended; requests to speak must be submitted by July 6, 2025, and written questions by July 20, 2025 - Shareholders can join the virtual meeting by clicking the VC/OAVM link on the NSDL e-voting platform after logging in[91](index=91&type=chunk) - Shareholders who wish to speak during the AGM must send a request to shares@drreddys.com by Sunday, July 6, 2025[91](index=91&type=chunk) - Shareholders can send questions in advance to shares@drreddys.com on or before Sunday, July 20, 2025[91](index=91&type=chunk) [AGM Information at a Glance](index=21&type=section&id=AGM%20Information%20at%20a%20Glance) This section provides a consolidated summary table of all critical information for the 41st AGM, including dates, times, links, and contact details for easy shareholder reference AGM Information Summary | Item | Details | | :--- | :--- | | **AGM Time and Date** | Thursday, July 24, 2025 at 11:00 a.m. (IST) | | **Mode** | Video conference and other audio-visual means | | **Cut-off Date for e-voting** | Thursday, July 17, 2025 | | **E-voting Period** | July 20, 2025 (9:00 a.m.) to July 23, 2025 (5:00 p.m.) | | **E-voting Website** | https://www.evoting.nsdl.com/ | | **Final Dividend Record Date** | July 10, 2025 | | **Dividend Payment Date** | On or before July 30, 2025 |

Financial Performance - The company reported a significant increase in revenue, with a total of $1.5 billion for the fiscal year, representing a 15% year-over-year growth[25]. - The user base expanded to 10 million active users, marking a 25% increase compared to the previous year[25]. - The company anticipates a revenue growth of 10% to 12% for the next fiscal year, driven by new product launches and market expansion strategies[28]. Research and Development - Investment in research and development reached $200 million, focusing on innovative drug formulations and advanced technologies[40]. - The company is developing a new biosimilar product expected to launch in Q3 2025, which could capture a market share of 20% in its category[49]. - The company has established partnerships with three contract research organizations to expedite the development of complex molecules[41]. Market Expansion and Acquisitions - The company plans to enter two new international markets by the end of the fiscal year, aiming to increase its global footprint[28]. - A strategic acquisition of a smaller biotech firm was completed for $300 million, enhancing the company's product pipeline[28]. - The company entered into a definitive agreement to acquire Haleon's global portfolio of consumer healthcare brands in the Nicotine Replacement Therapy category for a total consideration of up to Rs.56,121 million (GBP 500 million)[221]. Regulatory and Compliance - Regulatory compliance remains a priority, with ongoing investments in quality control systems to meet U.S. FDA standards[52]. - The U.S. FDA issued a complete response letter (CRL) in November 2024 regarding the biologics license application (BLA) for a biosimilar rituximab, with no certainty on approval timelines[57]. - Changes in regulatory requirements, such as India's UCPMP becoming mandatory in March 2024, may require adjustments in the company's approach[88]. Risks and Challenges - The company faces potential risks from increased competition in the generics market, which could lead to price erosion of up to 15%[30]. - The company faces increased logistics costs due to longer shipping routes and air shipments as a result of geopolitical tensions and military conflicts, impacting operational costs[80]. - The company is exposed to fluctuations in exchange rates, particularly as a significant portion of revenues are in currencies other than the Indian rupee, which may impact financial performance[130]. Economic and Political Environment - The current U.S. presidential administration has implemented numerous executive orders revising tariffs and international trade policies since January 2025, including universal tariffs on imported goods announced on April 2, 2025[58][59]. - The current economic conditions, including high unemployment and inflation, may negatively impact the company's growth and financial position[146][149]. - The company operates in regions susceptible to political and economic instability, which could adversely impact operations and cash flows, particularly in Latin America and the former Soviet Union[74][75]. Environmental, Social, and Governance (ESG) Factors - The company has set ambitious strategic ESG goals, but achieving them is dependent on external factors such as government regulations and the availability of renewable energy[159]. - The company must navigate complex ESG reporting requirements, which could affect its reputation and growth if not managed properly[154]. - The evolving environmental regulations may require the company to incur additional compliance costs, impacting its financial position[124]. Litigation and Legal Risks - The company is involved in various litigations regarding patent validity, which could affect its results of operations and financial condition[141]. - The company may face significant liabilities if it sells generic products before resolving patent litigation, which could adversely affect its business[125]. - The company is at risk of litigation related to off-label marketing practices, which could result in significant penalties and affect its operations[144]. Operational Challenges - The company is actively managing third-party relationships to ensure timely supply of active pharmaceutical ingredients (APIs) and raw materials, but any disruptions could lead to production capacity loss[95]. - The company may experience difficulties in attracting and retaining qualified personnel, which is critical for business development[98]. - Approximately 1.7% of the company's employees are part of various labor unions, which could impact production capacity and overall profitability if issues arise[164].

Core Insights - Alvotech has partnered with Dr. Reddy's Laboratories to co-develop a biosimilar candidate to Keytruda, which is used for various cancer types [1][2] - Keytruda generated worldwide sales of $29.5 billion in 2024, highlighting the potential market size for the biosimilar [2] - The collaboration aims to leverage both companies' strengths in biosimilars to expedite development and enhance global market access [2] Company Developments - The agreement stipulates that both parties will share responsibilities and costs associated with the development and manufacturing of the biosimilar candidate [2][3] - Alvotech recently acquired the R&D operations of Xbrane Biopharma for approximately SEK275 million (around $27 million), which includes a biosimilar candidate based on Cimzia [4] - HSBC has upgraded Dr. Reddy's Laboratories from Hold to Buy, increasing the price forecast from $14.44 to $16.9 [4] Market Performance - As of the latest update, Dr. Reddy's Laboratories (RDY) stock rose by 6.07% to $15.65, while Alvotech (ALVO) stock decreased by 2.49% to $10.56 [7] - Analysts often utilize earnings growth and fundamental research for valuation, while some traders rely on technical analysis for stock price predictions [5][6]

Core Insights - Dr. Reddy's Laboratories (RDY) has entered into a collaboration and license agreement with Alvotech (ALVO) to co-develop and commercialize a biosimilar candidate to Merck's Keytruda, a leading PD-L1 inhibitor [1][8] Group 1: Collaboration Details - The agreement entails that RDY and ALVO will jointly share all costs associated with the development and manufacturing of the biosimilar candidate [3] - Both companies will retain the rights to commercialize the product globally upon successful development [3][8] Group 2: Market Impact - The collaboration is expected to significantly enhance Dr. Reddy's biosimilar portfolio, particularly in emerging markets, and strengthen its capabilities in oncology [4][8] - Keytruda generated sales of $29.5 billion in 2024, with a year-over-year growth of 6% to $7.21 billion in Q1 2025, highlighting the potential market opportunity for the biosimilar [2] Group 3: Previous Agreements - RDY and ALVO had previously signed a license and supply agreement in 2024 for the commercialization of AVT03, a biosimilar candidate to Amgen's Prolia and Xgeva [9] - The FDA accepted a regulatory filing for AVT03 in March 2025, indicating progress in their biosimilar development efforts [9][10] Group 4: Strategic Focus - The introduction of AVT03 could enhance patient access to affordable treatment options for osteoporosis and other bone-related conditions, addressing a significant healthcare need [11][12] - Dr. Reddy's is actively diversifying its generics portfolio to strengthen its market position [12]

Group 1 - The article discusses Dr. Reddy's Laboratories (NYSE: RDY) and highlights a strong buy rating based on its lucrative valuation [1] - The author emphasizes a value-focused investment strategy, targeting stocks that are undervalued and have near-term catalysts [1] - The investment horizon mentioned ranges from one quarter to two years, indicating a medium-term investment approach [1] Group 2 - The author has over three years of active investing experience and has worked as a buy-side analyst at a boutique research firm and family offices [1]

Core Viewpoint - Dr. Reddy's Laboratories Limited reported better-than-expected fiscal fourth-quarter results, with earnings and revenues surpassing estimates, driven by growth in global generics revenues [1][2]. Financial Performance - The company reported fourth-quarter fiscal 2025 earnings of 22 cents per American Depositary Share (ADS), exceeding the Zacks Consensus Estimate of 20 cents per share, and up from 18 cents per ADS in the same quarter last year [1]. - Revenues for the quarter grew 20% year over year to $996 million, surpassing the Zacks Consensus Estimate of $867 million [1]. - For fiscal 2025, total revenues reached $3.8 billion, a 17% increase from $3.3 billion in fiscal 2024, with earnings per share totaling 79 cents compared to 78 cents in fiscal 2024 [9]. Segment Performance - Global Generics revenues amounted to INR 75.4 billion, reflecting a 23% year-over-year increase, driven by the acquired Nicotine Replacement Therapy portfolio, higher sales volumes, and new product launches [3]. - Pharmaceutical Services & Active Ingredients (PSAI) revenues were INR 9.6 billion, up 16% year over year, attributed to increased active pharmaceutical ingredients (API) sales volumes and new API product launches, despite adverse price variance [6]. - Revenues in the Others segment totaled INR 132 million, down 91% year over year [6]. Cost and Expenses - Gross margin declined by 300 basis points to 55.6% due to higher price erosion in generics and lower manufacturing overhead leverage [7]. - Research and development expenses increased by 6% year over year to $85 million, reflecting ongoing development efforts across generics, biosimilars, and novel oncology assets [7]. - Selling, general, and administrative expenses totaled $282 million, up 17% year over year, primarily due to increased sales and marketing investments [8]. Regulatory Updates - Dr. Reddy's and partner Alvotech announced the FDA's acceptance of a regulatory filing for AVT03, a proposed biosimilar of Amgen's Prolia and Xgeva, which could enhance patient access to affordable treatment options for osteoporosis [10][11]. - The biologic license application (BLA) for AVT03 was submitted under the FDA's biosimilar application process, with the potential to significantly improve treatment accessibility for a large patient population [12].

Group 1: Licensing Agreements - Dr. Reddy's Laboratories (RDY) and Bio-Thera Solutions have entered into commercialization and license agreements for two proposed biosimilars: BAT2206 (a biosimilar of JNJ's Stelara) and BAT2506 (a biosimilar of JNJ's Simponi) [1][2] - Under the agreement, Bio-Thera will manage the development, manufacturing, and supply of BAT2206 and BAT2506, while Dr. Reddy's will handle regulatory approvals and commercialization in Southeast Asia, including countries like Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam [6] Group 2: Market Impact and Strategy - The licensing deal is expected to significantly enhance Dr. Reddy's biosimilar portfolio in emerging markets, aiming to improve patient access to affordable medicines [2] - Bio-Thera plans to leverage Dr. Reddy's extensive resources and expertise in the generics industry to facilitate the availability of BAT2206 and BAT2506 in Southeast Asia, thereby accelerating patient access to high-quality biosimilars [3] Group 3: Product Details - BAT2206 is a human monoclonal antibody with potential applications in treating Crohn's disease and ulcerative colitis, among other autoimmune diseases, and is based on JNJ's Stelara, which is approved for various immune-related conditions in the EU [4] - BAT2506 is also a human monoclonal antibody, targeting conditions such as moderate to severe rheumatoid arthritis and ulcerative colitis, based on JNJ's Simponi, which carries warnings for serious infections and cancer risks [5] Group 4: Broader Initiatives - Dr. Reddy's has been actively diversifying its generics portfolio, including a recent partnership with Alvotech for the proposed biosimilar AVT03, which targets Amgen's Prolia and Xgeva [7][8] - The approval of AVT03 could significantly enhance patient access to affordable treatments for osteoporosis and other bone-related conditions, aligning with efforts to expand the availability of high-quality biologic medicines [9]

Core Viewpoint - Bio-Thera Solutions and Dr. Reddy's Laboratories have entered into exclusive commercialization and license agreements for two proposed biosimilars, BAT2206 and BAT2506, targeting Southeast Asia and Colombia [1][2][3] Group 1: Agreements and Responsibilities - Bio-Thera will handle the development, manufacturing, and supply of BAT2206 and BAT2506, while Dr. Reddy's will seek regulatory approvals and manage commercialization in Southeast Asia, including countries like Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam [2][3] - Dr. Reddy's will also gain exclusive commercial rights to BAT2206 in Colombia [2] Group 2: Product Information - BAT2206 is a proposed biosimilar to Stelara®, targeting conditions like Crohn's disease and ulcerative colitis, and is currently approved in the EU for multiple indications including moderate to severe plaque psoriasis and active psoriatic arthritis [4] - BAT2506 is a proposed biosimilar to Simponi®, which is used for moderate to severe rheumatoid arthritis and carries a Boxed Warning for serious infections and malignancy [5] Group 3: Company Background - Bio-Thera Solutions is a biopharmaceutical company based in Guangzhou, China, focused on developing innovative therapies and biosimilars for various diseases, including cancer and autoimmune disorders [6][7] - Dr. Reddy's Laboratories, headquartered in Hyderabad, India, is a global pharmaceutical company committed to providing access to affordable medicines, with a diverse portfolio including APIs, generics, and biosimilars [8]