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Sandoz responds to the US Court of Appeals judgment which upheld a ruling from the New Jersey District Court which declared the Amgen patents relating to (etanercept) valid. Sandoz stated that it will continue its efforts to make Erelzi® available in the US, and is evaluati...

The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwi...

BeiGene announces its has begun commercialising Xgeva® (denosumab) in China. Xgeva® was developed by Amgen, and is the first of the products to be commercialised by BeiGene under a January 2020 agreement.

Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.

Genentech files a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimilar), and violation of the “patent dance” provisions.

In a letter to the Editor published by the Washington Post, Keith Webber (former acting director of the FDA’s Office of Biotechnology Products and Office of Generic Drugs) highlighted the potential consequences of the legal brief filed in the US Supreme Court by the T...

Significant biosimilar activities this week include
June 20 | The NZ Herald reported a new study by NZ scientists which indicates that transgenic goats are capable of producing milk with high levels of cetuximab.
22 Jun 20 | Ankylosing Spondylitis News reported ...

Celltrion announces EU’s CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis...