As biosimilars begin to gain traction in the U.S. pharmaceutical market, the distinct labeling requirements applicable to them are likely to affect product liability litigation in this area, raising implications that are potentially distinct from those applicable to biologics and to small-molecule, generic drugs write Products Litigation and Counseling lawyers….
Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab). The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). According to Vice President and Team Lead of Medical…
During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar: GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell…
On August 25, 2020, the Association for Accessible Medicines filed a new Complaint challenging California’s Assembly Bill 824 (“AB 824”). Enacted in October 2019 and in effect as of January 1, 2020, AB 824 imposes a presumption of anticompetitive effect on certain agreements that involve generic or biosimilar manufacturers and…
On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA. According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.” This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that…
In its second quarter earnings release, Junshi Biosciences announced that its product candidate JS016 was approved to conduct a Phase 1 clinical trial in China. The trial is a randomized, double-blind, placebo-controlled study to evaluate the tolerability and safety of single-dose intravenous infusion of JS106 in healthy subjects. According to…
Last week, BeiGene and Bio-Thera Solutions announced that the companies had entered into a license, distribution, and supply agreement for BAT1706, Biothera’s Avastin® (bevacizumab) biosimilar, in China. According to the announcement, Bio-Thera has agreed to grant BeiGene the right to develop, manufacture, and commercialize BAT1706 in China, Hong Kong, Macau,…
We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection). Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market. SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product. SEMGLEE will be available in vials and pre-filled pens. The lead…
Today, Cadila Pharmaceuticals announced the launch of its adalimumab biosimilar, Cadalimab™, in India. HUMIRA® (adalimumab) is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis. Cadila’s press release noted that “[i]n an effort to strengthen their biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last…
Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…