Welcome to the Big Molecule Watch!

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.

IPR Updates Relating to Adalimumab and Rituximab

Last week, the Patent Trial and Appeal Board (“Board”) instituted inter partes review of two patents directed to methods of administering adalimumab for the treatment of psoriasis, based on petitions filed by Sandoz: IPR2017-02105 (challenging U.S. Pat. No. 9,090,689) and IPR2017-02106 (challenging U.S. Pat. No. 9,067,992). Separately, the Board issued…

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Immunex Files Reply In Support of Motion To Stay Dupixent® Patent Litigation

In the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, Immunex has filed a reply brief in support of its motion to stay the litigation pending Inter Partes Review of U.S. Patent No. 8,679,487 (“the ‘487 patent”), which Sanofi has opposed. Sanofi filed three IPR petitions on…

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AbbVie and Samsung Bioepis Announce Global Settlement of Adalimumab Disputes

Today, AbbVie and Samsung Bioepis announced that they have reached a global resolution of all intellectual property-related litigation relating to Samsung Bioepis’ biosimilar of Humira® (adalimumab), SB5, clearing the way for its commercialization in all approved markets worldwide.  SB5 has already received marketing authorization from the European Commission (EC) as…

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Commissioner Gottlieb Addresses Biosimilars at Conference

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars.  His comments largely tracked a statement that he made in early March. Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access. …

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LG Chem Tests LBEC0101, a Biosimilar to Enbrel (etanercept), in Rheumatoid Arthritis

The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published.  The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid…

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Wisconsin and West Virginia Pass Biosimilar Legislation

Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products.  Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on February 28, as the latest states to approve biosimilar access bills. On Wednesday, Wisconsin Governor Scott Walker signed Senate…

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Recent Biosimilar Industry Coverage

A number of media sources have covered new developments in the biosimilars space.  Here is a round-up of some highlights from this month. Reuters reports that biosimilars, including biosimilar versions of Rituxan and Herceptin, have begun to capture a large portion of the British biosimilar market, whereas approvals and adoptions…

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Update on Biosimilar Launches and Development

Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. According to the press release, this is the first…

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