Clover Biopharmaceuticals will adopt GE Healthcare’s centrally automated FlexFactory platform at its facility in Zhejiang, China where it plans to make a biosimilar to Amgen’s Enbrel.
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?
Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.
The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
Biosimilars will capture new patients in the first instance while existing patients will gradually switch over says Pfizer, a developer of both originator biologics and copycats.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
Samsung Bioepis will base its European operations in the UK at an entity set up to hold marketing authorizations for biosimilars it has filed for EMA review.
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.
Biogen Idec will make Samsung Bioepis’ Enbrel (etanercept) biosimilar at the Danish plant that supplies its originator products, Tysabri (natalizumab) and Avonex (interferon beta-1a).
As Celltrion anticipates applying for US FDA approval for its Remsima biosimilar in the first half of 2014, the company this week filed suit in US District Court in Massachusetts against Janssen seeking to invalidate patents that would stop such a launch.
Rani Therapeutics announced Wednesday that it has closed its Series B round of funding after pulling in more than $10m from Google Ventures, InCube Ventures and VentureHealth, a healthcare crowdfunding portal.
