• Regulatory NewsRegulatory News

    Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

    The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants. The FDA action follows Apotex’s initial request to withdraw the ANDAs in January 2018. FDA said it became aware of concerns involving material manufactured at the two Apotex facilities, at least one of which was named in each of the pulled ANDAs....
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    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
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    UK's MHRA: Apotex Site Does Not Comply With GMP Requirements

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant. A statement of non-compliance with good manufacturing practice (GMP) requirements highlighted the site’s non-complaint operations related to non-sterile products, packaging and quality control testing. "Due to the nature of the issues identified, batches not released to market are included in the ...
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    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
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    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
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    GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

    The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief. Background Under the Biologics Price Competition and Innovation Act (BPCIA) -- authorized as part of Obamacare -- biosimilars can be approved via an expedited pathway and then marketed after their reference biologics are exclusively marketed fo...
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    Health Canada Overruled on Apotex Import Ban

    A Canadian federal court has ruled against Health Canada’s decision to restrict pharmaceutical imports from two Apotex facilities in India, though the US FDA still bans products from these facilities. In its ruling from 14 October, the court noted that Health Canada and Health Minister Rona Ambrose proceeded unfairly and acted for an improper purpose. The ruling also requested Health Canada and Ambrose retract its statements on Apotex, which they did Tuesday. And altho...
  • Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants

    A Warning Letter sent by the US Food and Drug Administration (FDA) to generic manufacturing company Apotex, Inc. cites a number of "serious" current good manufacturing practice deficiencies found at two manufacturing sites maintained by the company-a rarity among FDA Warning Letters. The 21 February 2013 letter references a 13-24 August inspection of two Canada-based facilities operated by the company. Facility One: Toronto At the first facility, FDA claimed the compan...
  • FDA Approves Eleven Generic Versions of Plavix as Drug Goes Off-patent

    The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi's blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the latest product to go off the so-called "patent cliff." Many drugs are scheduled to lose their patent protection in the coming two years, marking huge potential losses to the bottom lines of numerous companies. Both Sanofi and BMS said they expect a "rapid, precipitous and mat...
  • Generic Boniva Approved, Marking Next Big Patent Expiry

    The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year. The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug. Boniva h...