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In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More
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. Read More
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 of its patents. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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 prices, according to a study. Read More
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. Read More
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 biosimilars. Read More