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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
Generic trade groups and patient advocacy organizations are taking competing stances in their recommendations for the FDA’s biosimilar labeling draft guidance. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug. Read More