Tagged as: Teva

Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented…

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Teva Receives Approval for First Ophthalmology Biosimilar in Europe

Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS.  Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The United Kingdom is…

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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

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International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf., Alvotech Germany GmbH, Alvotech Swiss AG, Alvotech USA Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., and…

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Recent Launches – Formycon, Bioeq and Boryung, Samsung Bioepis

On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus…

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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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Alvotech and Teva Announce Strategic Partnership to Collaborate in the U.S. Biosimilar Market

Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S.  Under the partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, and Teva will be exclusively commercializing the products in…

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Genentech Settles Rituximab Patent Dispute with Celltrion and Teva

On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents.  The…

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