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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...

Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Fujifilm Kyowa Kirin Biologics announces manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.

Outlook India reports Dr Reddy’s is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy’s Ph III trials of a proposed rituximab biosimilar are progressing as planned.

Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

AbbVie and Sosei Heptares announce a $409M deal to discover and develop new immunology drugs.  The agreement covers the drug-discovery, development and commercialisation of small-molecule medicines that target autoimmune and inflammatory diseases using the G protein-coupled...