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.

Amneal Launches RELEUKO (filgrastim-ayow) in the United States

On November 22, 2022, Amneal Pharmaceuticals, Inc. (“Amneal”) announced the commercial launch of RELEUKO, a biosimilar referencing Neupogen.  RELEUKO is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy.  RELEUKO is Amneal’s second U.S. biosimilar launch.  As we previously reported, Amneal announced the launch of its first…

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FDA Approves Eli Lilly’s REZVOGLAR As the Second Interchangeable Insulin Glargine

On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as interchangeable to LANTUS.  Regarding REZVOGLAR’s approval as interchangeable, FDA stated: “This approval furthers FDA’s longstanding commitment to support a competitive marketplace for…

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The UK’s MHRA Updates its Guidance on Licensing of Biosimilars

On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a biosimilar and reference medicinal product (“RP”).  The UK’s Guidance now recognizes that “[o]nce authorised, a biosimilar product is considered…

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International Biosimilar Market Updates

Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe On November 14, Stelis Biopharma Limited (Stelis), the biologics arm of Strides Pharma Science Limited, announced that its first biosimilar product KAULIV received a positive recommendation from European Medicines Agency (EMA) for granting market authorization.  KAULIV is a biosimilar referencing…

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Organon Launches HERCEPTIN and AVASTIN Biosimilars in Canada

Organon, a global woman’s health company, recently announced its launch of two biosimilar products in Canada. On November 7, Organon announced the launch and availability of AYBINTIO in Canada.  AYBINTIO is a biosimilar product referencing AVASTIN (bevacizumab) and is approved for adults with certain aggressive forms of cancers, including metastatic…

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China Approves World’s First Denosumab Biosimilar

Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.  Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…

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STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved…

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PTAB Issues Final Written Decisions Finding Claims of Regeneron’s Aflibercept Patents Invalid

On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069.  The PTAB ruled in Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same…

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PTAB Grants Petitioner Celltrion’s Motion To Submit Supplemental Information in Tocilizumab IPR

The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. As we previously reported, this is one of two…

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Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held on Thursday, January 19, 2023. As we have previously reported, President Biden issued an Executive Order…

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