The National Medical Products Administration (NMPA) has released the 61st batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 57 new specifications and 18 specifications with modifications, highlighting the ongoing efforts to ensure the quality and consistency of generic drugs in China.
Inclusion of Biogen’s Spinraza
Notably, the list includes Biogen’s Spinraza (nusinersen), a therapy for spinal muscular atrophy (SMA). Spinraza was initially approved in China in February 2019 with a price tag of RMB 70,000 (USD 9,659) per dose. The drug saw its price reduced to RMB 55,000 (USD 7,589) in 2021 when it was included in the National Reimbursement Drug List (NRDL). The final price per shot was set at RMB 33,180 (USD 4,578), making the therapy more accessible to patients.
Impact and Future Outlook
The inclusion of Spinraza in the NMPA’s reference drug list underscores the importance of ensuring high-quality generic versions of critical therapies. This move is expected to facilitate the development and approval of generic versions of Spinraza, potentially reducing costs further and improving access for patients with spinal muscular atrophy. The ongoing GQCE work by the NMPA is crucial in maintaining the quality and efficacy of generic drugs in the market.-Fineline Info & Tech
