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The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India. Read More
The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced in July. Read More
An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. Read More
The U.S. Supreme Court has asked the solicitor general to consider if a lower court erred in mandating that Novartis wait six months after approval of a biosimilar before going to market. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More
The second highest court in the land rejected Mylan’s requested rehearing in two patent lawsuits, leaving the company with few options for avoiding the cases. 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
The introduction of biosimilars to certain European countries has lowered drug prices by 50 percent to 60 percent in certain therapy areas, a report says. Read More