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Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.  The approval was granted base...

Eli Lilly has announced a $1B investment to build a new biotech facility in Raheen (Ireland) for the manufacture of on-market monoclonal antibodies (mAbs).  The site is expected to start production of Lilly’s new clinical products in 2026.  The company said that this invest...

The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week.  The case arises from a Federal Court decision which invalidated claims in two Amgen patents (8,829,165 and 8,859,741) relating to Repatha® (evolocumab) which it...

Significant biosimilar activities this week include:
22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents
21 March 2023 | CN | China’s NMPA accepts BLA for Boan Biotech’s biosimilar to Amgen’s Xgeva® (denosumab)<...

Takeda Pharmaceuticals announced that it received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market its subcutaneous (SC) formulation of vedolizumab, Entyvio®.  The approval covers both pens and syringes for SC injection.  The SC pr...

A study published in Rheumatology and Therapy has found that Mabpharm’s infliximab biosimilar candidate CMAB008 was equivalent to Janssen’s Remicade® in patients with moderate-to-severe rheumatoid arthritis treated with basic MTX.  Remicade® is produced in mouse myeloma SP2...

Newfoundland and Labrador and Yukon each announced implementation of biosimilar switching policies consistent with Ontario and seven other provinces in Canada.  In Yukon from 3 April 2023, patients enrolled in the Pharmacare and the Chronic Disease and Disability Program wi...

A study published in Clinical and Experimental Rheumatology found that patients with rheumatoid arthritis and psoriatic arthritis (PsA) experienced a worsening in the patient global assessment when they switched from AbbVie’s Humira® (adalimumab) to Samsung Bioepis’ Imraldi...

PTAB instituted Celltrion’s IPR challenges to US 10,888,601 (decision here) and US 10,130,681 (decision here) and Samsung Bioepis’ IPR challenge to US 10,888,601 (decision here).  PTAB also granted Celltrion and Samsung Bioepis’ motions to join these IPRs with the earlier I...

Regeneron and Sanofi announced European Commission approval of Dupixent® (dupilumab) for the treatment of children aged six months to five years old with severe atopic dermatitis.  Dupilumab is the only targeted medicine to treat this condition in young children approved in...