A recent court ruling and a new publication on guidelines for biosimilars in India may offer further guidance on what biosimilar and biologic stakeholders can expect from Indian regulatory authorities. In late March, India’s Central Drugs Standard Control Organization (CDSCO) published Proposed Revised Guidelines on Similar Biologics (2016), offering guidance…
Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….
On June 24, 2015, the UK’s High Court of Justice Patents Court invalidated a Genentech patent (EP 1037926 (“the ’926 patent”)) for the combined use of Herceptin (trastuzumab) in combination with the chemotherapeutic taxane for treatment of HER2-positive breast cancer. Hospira brought this action as part of a series of patent…