The U.S. Supreme Court has declined to hear a case on whether all biosimilar makers must give a six-month notice before bringing an FDA-approved product to market, even when disclosures…

Generic approvals and rejections were little changed from November, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Source: Generic Line

A majority of patent settlements reached last year in the European Union restricted the market entry of generics, according to a European Commission report. Source: Generic Line

Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Source:…

Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Source: Generic…

European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. Source: Generic Line

The U.S. Supreme Court has paved the way for Pfizer’s Hospira to develop a generic version of a Merck unit’s skin infection therapy after denying an appeal to uphold several…

As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Source: Generic Line

Amgen is suing generics maker Sandoz, claiming that Sandoz’s attempts to market a biosimilar for the blockbuster bone marrow drug Neulasta infringes on two of its patents for the drug.…

While retail prices for generic cancer drugs may be the highest in the U.S., these medicines aren’t necessarily affordable in poorer countries such as India and China despite their lower…