In a dynamic landscape of pharmaceutical developments, Biocon Biologics (Biocon) faces a regulatory hurdle with a complete response letter from the US Food and Drug Administration (FDA), while Meitheal Pharmaceuticals expands its reach through a strategic licensing agreement with Tonghua Dongbao Pharmaceutical.
Biocon Biologics’ CRL
In October 2023, Biocon received another complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning their insulin aspart biosimilar.
In October 2022, FDA had previously issued a CRL for Biocon’s insulin aspart biosimilar [1]. Although no outstanding scientific issues with the product were identified, the CRL referenced the Form 483 observations noted during the pre-approval inspection of Biocon’s integrated insulins manufacturing facility at Malaysia in August 2022.
Now, the CRL again does not identify any outstanding scientific issues with the product. However, it references the requirement for a satisfactory resolution of deficiencies from the 2022 pre-approval inspection (PAI) of Biocon’s Malaysia facility for Insulin Aspart.
Biocon had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022, and a re-inspection of the Malaysia facility, was needed to proceed with the application. In February 2023, Biocon submitted a report from an independent third-party consultant, providing evidence of CAPA completion and effectiveness. However, the PAI re-inspection was not scheduled prior to the goal date of 6 October 2023. As such, Biocon has now received yet another CRL for the Malaysia facility.
Biocon now faces two CRLs from FDA, pertaining to their facilities in Malaysia and Bangalore, India [1].
Meitheal partner with Tonghua Dongbao to commercialise three insulin biosimilars
In September 2023, Meitheal Pharmaceuticals signed an exclusive licensing agreement with the China-based Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars, including an insulin aspart, in the US.
Meitheal hopes to bring three biosimilar insulins to market through their partnership with Tonghua Dongbao.
The insulin biosimilars include two rapid-acting insulins, insulin lispro and insulin aspart, and the long-acting insulin glargine. The rights were acquired by Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical.
Under the terms of the agreement, Tonghua Dongbao and Nanjing King-Friend Biochemical are responsible for the development and supply of all three insulin biosimilars. The insulin biosimilars are expected to be approved by FDA in 2026. After this, Meitheal will have exclusive US marketing rights. All three companies will also share the royalties from the US sales.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 21]. Available from: www.gabionline.net/biosimilars/news/biosimilar-advances-for-alvotech-teva-and-setback-for-biocon-biologics
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