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Biosimilars Council: Express Scripts’s National Preferred Flex Formulary is an Opportunity for Biosimilars

Express Scripts has announced “a new drug reimbursement list with lower U.S. prices for brand-name medications, as a way to encourage drugmakers to move away from paying rebates after a prescription is filled.”  You can read Express Scripts’s press release here.  According to the Biosimilars Council, this could provide a particular opportunity…

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Coherus Enters into Prime Vendor Agreement with Apexus that Includes Udenyca™

Last week, Coherus BioSciences, Inc. announced that it had entered into a 340B prime vendor program contract agreement with Apexus, LLC.  This agreement includes Udenyca™, which, as we reported last month, is the second biosimilar of Neulasta® (pegfilgrastim) to have received FDA approval.  According to the press release, Apexus’s president, Chris Hatwig, stated…

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Global Biosimilar Development Updates

Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported: Today, December 3, 2018, Celltrion announced that the European Medicines Agency (EMA) has accepted Celltrion’s Extension Marketing Authorisation Application for…

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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties…

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FDA Approves First Rituximab Biosimilar

On Wednesday, the FDA approved the first biosimilar to Genentech’s RITUXAN®. The FDA’s press release noted that Teva and Celltrion’s biosimilar TRUXIMA® (rituximab-abbs) is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. TRUXIMA® is indicated for treatment of adult patients for: Relapsed or…

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European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…

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