Learn English Grammar From A–Z
- The FDA has been trying to get its regulatory head around the issue of biogeneric equivalency, but it isn't easy.
- Large growth is expected to come on the back of increased partnering activity, transition to product-driven models, growth in the biogenerics market and government initiatives to encourage investment and expansion.
- "You get one crack at it," said Robert Coughlin, president of the Massachusetts Biotechnology Council, speaking of the task of drawing up a licensing system for "biogenerics."
- CCPM coalition members urged Congress to fix or drop the current biogenerics provision.
- At the same time that Amgen is getting ready to launch its own biosimilars, Amgen and other biotechs are campaigning state governments to make it harder to substitute a biogeneric for a brand.
- Some biotech drug manufacturers are lobbying state legislators to restrict access to biosimilar (or biogeneric) versions of expensive brand medications, the Pharmaceutical Care Management Association (PCMA) said today.
- "I feel that a value of $1 billion is reasonable for a proven technological platform in the generics sector, especially in biogenerics, which currently very much interests the major firms."
- If competing firms are permitted to manufacture them, biogeneric versions of the off-patent medicines could command $5 billion next year.
- Rules in the U.S. are still unclear, making it difficult for companies to win approval to market biogenerics there.