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.

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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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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Coherus Neulasta biosimilar loses preferred status at Express Scripts

Last week it was announced that Coherus BioSciences’s pegfilgrastim biosimilar Udencya would be excluded from Express Scripts’s preferred formulary starting January 1, 2021. The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s Fulphila and Sandoz’s Ziextenzo.

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Johnson & Johnson Announces Acquisition of Momenta For $6.5 Billion

Johnson and Johnson announced that it has entered into an agreement to acquire Momenta Pharmaceuticals, Inc. for $6.5 billion.  The acquisition gives J&J’s Janssen unit full global rights to Momenta’s nipocalimab (M281), an anti-FcRn antibody designed to treat a number of autoantibody-driven disorders, including generalized myasthenia gravis (gMG), warm autoimmune…

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