Biosimilar and Biologic Updates in China: Bevacizumab, Etanercept, Tislezumab, Infliximab, Eculizumab, Adalimumab

The past few weeks have seen the following biosimilar developments in China:

  • On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been approved to treat advanced, metastatic or recurrent non-small-cell lung cancer and metastatic colorectal cancer.
  • On December 30, 2019, Clover Biopharmaceuticals announced the initiation of a Phase III clinical trial in China of SCB-808, a proposed biosimilar to ENBREL (etanercept).  According to Clover’s press release, SCB-808 is in development as a pre-filled syringe formulation for the treatment of rheumatic diseases, including ankylosing spondylitis and rheumatoid arthritis.  The press release explains that previous etanercept biosimilars in China were approved as lyophilized powder formulations, which must be reconstituted by trained medical personnel before subcutaneous injection into patients, received approval before implementation of the China Food and Drug Administration’s Technical Guideline for Development and Evaluation of Biosimilars, “and were not compared to the originator drug Enbrel in clinical trials to demonstrate their bioequivalence.”
  • On January 3, 2020, China approved TISLEZUMAB, an anti-PD-1 monoclonal antibody, for Hodgkin’s lymphoma. TISLEZUMAB was developed by BeiGene but is being manufactured locally by Boehringer Ingelheim. This is the first biopharmaceutical approved under China’s recently modified Drug Administration Law that adopted a marketing authorization holder system similar to the US and EU. Previously, drug developers had to have their own manufacturing capacity in China.
  • On January 6, 2020, Sorrento Therapeutics announced that its partner Mabpharm filed a New Drug Application in China for its REMICADE (infliximab) biosimilar.  Infliximab is an injectable monoclonal antibody that is used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and of plaque psoriasis.  According to the press release, Sorrento owns the global rights to the Mabpharm infliximab “biobetter” antibody outside of China and plans to file a Biologics License Application in the United States by the end of 2020.
  • On January 10, 2020, Samsung Bioepis Co., Ltd. and AffaMed Therapeutics announced that the China National Medical Products Administration (NMPA) has approved the Clinical Trial Application (CTA) for SB12, also referred to as AMT904, a proposed biosimilar to SOLIRIS (eculizumab).  SB12 is in development for the treatment of paroxysmal nocturnal hemoglobinuria.  The CTA approval grants the start of Phase III clinical trials in China.  The press release states that SB12 is the only eculizumab biosimilar candidate to be granted Investigative New Drug (IND) approval in China. It further explains that while Samsung Bioepis has responsibility for its global clinical trials, AffaMed has exclusive rights to commercialize the treatment in China and Singapore.
  • On January 10, 2020 Bio-Thera Solutions, Ltd. announced the launch of its adalimumab biosimilar, QLETI, in China. QLETI is the first adalimumab biosimilar approved by the China National Medical Products Administration (NMPA) and Bio-Thera’s first approved product.
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