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The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More
Pharma companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of drug’s approval or rejection, according to April 1 guidance that sets specific timelines for every step of the dispute resolution process. Read More
Drugmakers are being asked to partner with the U.S. National Institutes of Health, academics and biotechnology companies to develop new antibiotics, under a White House plan announced March 27. Read More
A German government agency says the EU’s plan for implementing a clinical trials database lets drugmakers withhold too much information — including study protocols, methods and trial results — under the exemption for commercial confidentiality. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued last month. Read More
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
High-ranking U.S. Food and Drug Administration officials visiting India have laid out a new approach to facility inspections for Indian manufacturers that would reward firms if their quality management system exceeds minimum compliance requirements. Read More