Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

Further Recent Biologics Applications

We are continuing to see regulatory and commercial activity in the biologics space with companies pursuing new indications and approvals. Amgen announced today both the submission of a supplemental BLA to the FDA and an application for a variation to the marketing authorization to the EMA for XGEVA (denosumab).  With these applications,…

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Amgen obtains FDA Priority Review for BLINCYTO (blinatumomab)

Amgen announced last week that the FDA has granted priority review for a supplemental BLA for BLINCYTO (blinatumomab).  BLINCYTO received approval in 2014 for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.  With the sBLA, Amgen seeks to add an indication for Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic…

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Roche’s Subcutaneous Rituximab Gets Unanimous Recommendation From Fda Advisory Committee

In a press release, Roche announced today that FDA’s Oncologic Drug Advisory Committee has voted unanimously in favor of a subcutaneous injection of rituximab for the treatment of certain blood cancers, including previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular…

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Eleven Professors File Amicus Brief in Sandoz v. Amgen

As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and policy, and the economics of the biopharmaceutical industry,” and “are concerned with the…

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FDA Approves Genentech’s Ocrevus (ocrelizumab)

gloved hand withdraws drug solution with syringe

FDA announced today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”).  Ocrevus is the first drug approved by the FDA for treatment of PPMS, which the CDC estimates affects 15% of patients with multiple sclerosis….

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FDA Approves Sanofi and Regeneron's Dupixent (dupilumab)

Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.  As we reported last week, Sanofi and Regeneron have filed…

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