This decision represents the first occasion in which a biosimilar applicant proceeding under the Biosimilar Price Competition and Innovation Act (BPCIA) has achieved a district court victory. The ruling was made on September 6 by Judge Cohn of the Southern District of Florida, who ruled that the manufacturing process for both products did not infringe, either literally or by equivalents, Amgen's US Patent No. 8,952,138, which expires on July 29, 2031
"Our patent infringement victory underscores the urgent need for the Supreme Court to rule that biosimilar applicants can provide their notice of intent to market prior to securing FDA approval for their products, as intended by the BPCIA," added Lydeamore.
The petition submitted to the US Supreme court states: "In this instance, the Circuit's bar will operate only to keep a non-infringing, cost-saving FDA-approved biosimilar product out of the hands of consumers for an additional six months."
This is the second petition filed this year asking the Supreme Court to address the question. Earlier this year, the Supreme Court asked the US Solicitor General to weigh in on this issue.
Biosimilars are medical treatments that are highly similar to another biopharmaceutical product that has previously been licensed. Biosimilars are required by the FDA to demonstrate that there are no clinically meaningful differences in terms of the safety, purity, and potency between the biosimilar product and the previously licensed biologic drug.
Apobiologix, a part of the Apotex group focused on biologics innovation, is a pioneer in the field of biosimilars. The company has a robust pipeline of biologic products, and aims at providing patients and providers with healthcare products that offer high quality and value.
Apotex is the largest Canadian-owned, pharmaceutical company with sales in 115 countries across the world. Founded in 1974, Apotex is one of the world's leading suppliers of high-quality, affordable pharmaceutical products.
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