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.

Alvotech and DKSH Extend Partnership in Asia

Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets.  The press release does not name the biosimilar candidates, but states that they “address[] multiple therapeutic areas.”  The companies previously entered into an exclusive license partnership for Alvotech’s adalimumab…

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Accord Healthcare has Launched Zercepac® (Trastuzumab) Biosimilar in the UK

Following approval by the European Commission in July, last week Accord Healthcare announced the launch of Zercepac® a biosimilar to Herceptin® in the United Kingdom.  According to the press release, Zercepac® is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and previously untreated…

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Lotus and CKD Announce Biosimilar Collaboration

On September 19, 2020, Lotus Pharmaceutical Co., Ltd. (“Lotus”) and Chong Kun Dang Pharmaceutical Corp. (“CKD”) announced that they have entered into a commercialization agreement in connection with CKD’s biosimilar darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure.  According to Lotus’ press…

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Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…

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Health Canada Approves Merck’s Etanercept Biosimilar for New Indications

On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications: Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy; Pediatric patients ages 4 to 17…

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Low-Cost Syringe Technology May Enable Subcutaneous Injection of Viscous Formulations

In late August, MIT announced that a group of MIT researchers led by Kripa Varanasi published a paper describing a low-cost technology for administering biological drug formulations otherwise too viscous to be injected using conventional medical syringes.  The system utilizes a syringe having an inner barrel containing viscous drug fluid and an outer barrel…

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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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