Stay tuned for an in depth analysis of the arguments.
Stay tuned for an in depth analysis of the arguments.
Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision under the Food and Drug Administration Amendments Act (FDAAA), which was enacted in 2007, that provides the FDA with…
The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized by the amendments will be dedicated to, among other things, expediting the review process for…
Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products that satisfied the final determinations so recognized and listed by the federal department of…
As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries concerning (among other things) intellectual property and pharmaceutical products. While President Obama had approved a deal on…
With the pre-trial conference set to begin on February 6, 2017, the parties in Janssen v. Celltrion have filed several motions seeking to exclude or limit certain evidence and testimony that may be offered at trial. Expert Testimony Celltrion has filed a motion to exclude the opinions of Janssen’s proffered expert…
Goodwin announced today the release of its 2016 BPCIA Litigation Update and Thinking of Investing In a Biosimilars Product? The 2016 BPCIA Litigation Update recaps a busy year in the legal world of biosimilars, offering background, legal analysis and the status of the year’s most pivotal cases. Thinking of Investing…
The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and functional data provided by the applicants, the EMA will provide recommendations on which tests/studies should be…
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”). The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…
Bloomberg BNA reported that a panel of regulators at the DIA 2016 Biosimilar Conference in Washington highlighted the differences among biosimilar regulations internationally and the ongoing changes as countries revise their biosimilar guidances. For instance, in Canada, biosimilars are regulated as new biologics as opposed to the U.S.’s abbreviated pathways…