Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions and Answers” and the final guidance “Interpretation…
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…
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In October, Amgen filed an amended complaint, reducing the number of asserted patents to four,…
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…
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…
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…
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…
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…
AbbVie filed its opening claim construction brief in its litigation with Boehringer Ingelheim (BI). AbbVie asserted eight patents against BI. The parties narrowed their dispute to two claim terms in three patents. U.S. Patent Nos. 9,018,361 (“’361 patent”) and 9,090,867 (“’867 patent”) are directed to methods of manufacture of adalimumab. U.S….
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion argued that under the claims of the patent, the salts and protein used to produce pegfilgrastim must be…