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Mexican regulators have laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
Canada has fired back in its dispute with Eli Lilly over court rulings that invalidated patents covering two of the drugmaker’s therapies, charging that Lilly has grossly mischaracterized the country’s patent policies.
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The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Feb. 17, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
A German regulator says European Medicines Agency plans for implementing its clinical trials database lets drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercial confidentiality. Read More
Sponsors spend upwards of 23 million hours complying with clinical trial requirements, from requests for INDs to submission of NDAs, the FDA says. Read More
A federal judge has sided with the FDA in its decision to strip Ranbaxy of generic approval and first-filer rights to Nexium and Valcyte, meaning company’s efforts to control the generic market for the two drugs could be over unless it appeals. Read More
The HHS Inspector General is urging the Centers for Medicare & Medicaid Services to expand price substitutions for Medicare Part B drugs, saying the move could save millions of dollars a year. Read More
The UK’s healthcare cost watchdog today gave a positive nod to Gilead Sciences’ hepatitis C combination therapy Harvoni for certain genotype 1 and 4 patients. Read More
Generics maker Natco Pharma has signed an authorized generic licensing deal with Gilead to produce its pricey blockbuster hepatitis C drug Sovaldi in India and 90 other developing countries. The agreement likely signals an end to Natco’s fight to have Sovaldi’s patent protection in India revoked. Read More