Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Source: Generic Line

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:…

The majority of physicians in the U.S. are familiar with biologics and biosimilars, but many lack the technical knowledge of their structural and therapeutic differences. Source: Generic Line

Biopharmaceutical firm Biocad has filed suit against Roche and its Genentech subsidiary over their alleged use of predatory pricing practices in Russia to decimate the sales of the Russian drugmaker’s…

Complete Response Letters for generic drug applications have finally taken a dip in 2016. Source: Generic Line

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…

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.…

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