Apobiologix's Biosimilar Pegfilgrastim, Lapelga™ Approved in Canada
On April 5, Health Canada approved pegfilgrastim biosimilar Lapelga. This marks the first pegfilgratim biosimilar approved in Canada.
Apobiologix Announces Participation in BBCIC Consortium
Apobiologix has joined The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) as a participating organization.
Apobiologix Continues To Move Forward With FDA Review Process
Supreme Court indicates that there will be no differentiation between companies following the patent dance and those that do not.
Apobiologix Announces Victory Over Amgen in Biosimilar Patent Case
Toronto, ON - Announcing an unprecedented positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) and Lapelga (pegfilgrastim) products, Apobiologix also indicates that the company today filed a Petition for Certiorari with the US Supreme Court.
Apotex's Grastofil™ (Filgrastim) and Lapelga™ (Pegfilgrastim) Biosimilar Products Determined Not to Infringe an Amgen Patent, Clearing Way for Launch Following Regulatory Approval
Weston, FL - On September 6, Judge Cohn of the Southern District of Florida ruled, following a bench trial, that Apotex's filgrastim and pegfilgrastim biosimilar products do not infringe a method of manufacturing patent enforced by Amgen.
Apobiologix Competes in KEYS100 Race to Support Local Florida Cancer Foundation
Key West, FL - On May 20-21, a team of dedicated Apobiologix employees and Benchworks partners joined forces to run in the KEYS100 Ultramarathon Race which exclusively benefited "The Cancer Foundation of the Florida Keys, Inc." This organization has been the primary recipient of the KEYS100 funding for the past 7 years.
Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Filgrastim (Grastofil™).
Company currently has 2 biosimilar applications (filgrastim [Neupogen™] and pegfilgrastim [Neulasta™]) under active review by FDA.
Toronto, ON - Apotex, Inc., a rising competitor in the global biosimilars market, announced today that, as of February 13, 2015, the US Food and Drug Administration has accepted for filing the company's application for filgrastim [Grastofil™], a biosimilar version of Amgen's Neupogen™.
Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Pegfilgrastim.
Believed to be the first company to have a biosimilar filing for Amgen's Neulasta® accepted for review by FDA.
Toronto, ON - Apotex, Inc, the largest Canadian-owned pharmaceutical company, announced today that the US Food and Drug Administration has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta®. The product has been jointly developed with Intas Pharmaceuticals Ltd. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).
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