Tagged as: biosimilar

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar.  According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…

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Pfizer Receives European Approval For Avastin® (Bevacizumab) Biosimilar

Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma…

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European Commission Releases Pharmaceutical Anti-Competition Report

The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space.  The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and…

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Alvotech Raises US$300 Million To Boost Biosimilar Pipeline

Alvotech announced today that its current product pipeline of “six biosimilar monoclonal antibodies aimed at treating cancer, autoimmune, inflammatory and other diseases” will receive an injection of capital from funds raised through a private bond offering. Having raised US$300 million, Alvotech plan to use the net proceeds “to fuel continued…

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AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab).  According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…

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Hospira Appeals $80 Million Judgment in Epoetin Alfa Biosimilar Case

As we reported, last month in the Amgen v. Hospira litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, the Delaware district court entered final judgment against Hospira, awarding Amgen $70 million in damages and approximately $10 million in pre-judgment interest, plus post-judgment interest in an amount to be determined at a…

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Boehringer Ingelheim Announces Positive Phase III Results for Its Adalimumab Biosimilar

On September 12, 2018, Boehringer Ingelheim announced positive results from a Phase III clinical trial for its approved adalimumab biosimilar, Cyltezo®. The clinical trial compared the efficacy, safety and immunogenicity of Cyltezo® and Humira® in patients with moderate-to-severe chronic plaque psoriasis.  According to Boehringer Ingelheim, the study confirmed equivalence of Cyltezo®…

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STADA Acquires Majority Stake in Epoetin Biosimilar Licensor BIOCEUTICALS

On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”).  According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS  from its co-shareholders to bring its total stake to 51.34 percent.  BIOCEUTICALS…

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Biosimilar Litigation Updates

Below is an update on recent developments in several litigations involving biosimilar products. Amgen v. Sandoz (filgrastim, pegfilgrastim): As we previously reported, the district court granted summary judgment of non-infringement in favor of Sandoz in the Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars. Amgen filed…

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