Tagged as: Enbrel

Year in Review: Top Legal Developments of 2023

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market.  The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…

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BREAKING NEWS - HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program

HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…

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Delaware District Court Adopts Magistrate Judge’s Report and Recommendation Denying Amgen’s Motion to Dismiss Regeneron’s Antitrust Claims, Overruling Amgen’s Objections

As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., 22-cv-697 pending in the district of Delaware.  On February 24, 2023, Amgen filed its Objections to the Report…

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Pfizer Files Lawsuit in Australia to Halt Sales of BRENZYS (etanercept)

Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept).  Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled “Production of polypeptides,” with claims directed to cell…

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Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

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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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Lupin, Mylan Launch Etanercept Biosimilar in Germany

Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…

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Sandoz Stipulates to Infringement of Certain Asserted Claims Prior to Etanercept Biosimilar Trial

As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi. Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of…

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DEAL WATCH: Lupin and Mylan Announce Partnership to Commercialize Etanercept Biosimilar

Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept).  Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…

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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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