仿制药上市遇阻！科伦制药等3家药企首仿失利，布立西坦口服溶液、比拉斯汀口服溶液首仿齐折戟

Core Insights - The National Medical Products Administration (NMPA) has rejected the market entry applications for two oral solution drugs, Brivaracetam and Bilastine, from three companies, indicating a setback for these promising first-generic opportunities in the industry [1] Group 1: Brivaracetam Oral Solution - Brivaracetam is recognized as an important third-generation anti-epileptic drug, noted for its rapid onset, good tolerability, and superior safety profile, making it a new option for treating refractory epilepsy [4] - The original product has shown stable performance in the global market, with annual sales reaching hundreds of millions of dollars [4] - Despite having a first-generic qualification for the tablet form obtained by one company last year, the oral solution form has faced multiple failures in market entry applications over the past two years [4] - Currently, only one company has a similar product in the late-stage review process, focusing on pharmaceutical aspects, which could potentially fill the market gap if successful [4] Group 2: Bilastine Oral Solution - Bilastine is a second-generation long-acting antihistamine that has gained attention for its rapid effectiveness and lack of significant sedation side effects [5] - The original tablet form has recently entered the Chinese market, and the first-generic tablet has been approved, establishing an initial market [5] - Similar to Brivaracetam, the path for the oral solution form of Bilastine has been fraught with challenges, with a total of seven companies' applications having been rejected so far [5] - Despite setbacks, over fifteen companies have submitted new applications for the Bilastine oral solution, which are currently under review, drawing significant industry interest [5] Group 3: Industry Implications - The simultaneous rejection of applications for both drugs signals a clear message to the industry: the traditional "first-generic" strategy is facing increasingly stringent review challenges, particularly for dosage forms with technical barriers like oral solutions [6] - Regulatory requirements for product quality, pharmaceutical research, and bioequivalence are becoming more detailed and precise, where any shortcomings can lead to failure [6] - This shift indicates that competition in the generic drug market is evolving from a simple "speed race" to a deeper "quality and technology competition," emphasizing the need for companies to invest in research and development, understand processes thoroughly, and maintain strict production quality to succeed in a competitive market [6]