Welcome to the Big Molecule Watch!

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Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

Samsung Bioepis Announces Phase 3 Exploratory Analyses Results of AYBINTIO (Bevacizumab)

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…

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EMA Recommends Blenrep, Adakveo, and Equidacent for Approval

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…

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AAM Renews Challenge to California’s Law Targeting Pharmaceutical Patent Infringement Settlements

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…

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NeuClone Announces Active Development of Biosimilars Referencing OPDIVO and KEYTRUDA

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…

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Junshi Biosciences to Study JS016, a Novel Coronavirus Neutralizing Antibody Product Candidate

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…

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Bio-Thera Solutions and BeiGene Announce Agreement for the Rights to Bio-Thera’s Avastin Biosimilar BAT1706 in China

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,…

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Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

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…

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Cadila Pharmaceuticals Announces Launch of Fourth Biosimilar in Two Months

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…

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Lupin, Mylan Launch Etanercept Biosimilar in Germany

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…

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