To balance this abbreviated pathway for development and approval of biosimilar and interchaneable products with incentives to develop innoative new products, the BPCI Act also provides exclusivity to manufacturers of certain biological products. FDA

Hi again, I have two questions, and since they are in one sentence, I would like to post it once. If I cannot, please let me know.

  1. In this sentence, does balance mean the following definition?

    [transitive] to create or preserve a good or correct balance between different features or aspects Macmillan

  2. Does exclusivity mean the right to monopolize here? When I looked for the word, it only says

    the state of being the only person, group of people, or organization that is allowed to have or do somethin Cambridge

1 Answer 1

  1. Yes the FDA intends to offer incentives/rewards to these companies in exchange for them bringing innovation to the market i.e. lower drug costs. The worry is that these companies will reap the rewards, yet provide little/no innovation.

  2. Yes that is one of the rewards. There is BIG money in patenting novel and useful drugs, and an exclusivity arrangement (whilst not lasting as long as a patent) is a very juicy prize. Eventually, the exclusivity rights will end and the drug will become available for much cheaper from lots of different companies.

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