Biotech Firms, Billions at Risk, Lobby States to Limit Generics

(Ref: The New York Times)
  • Some of the nation's largest biotechnology companies are intensively lobbying states to limit access to biosimilars, The New York Times reported.
  • Bills have been introduced in several states that would prevent pharmacists from substituting biosimilars for branded biologics, as proponents argue that the measures are needed to protect patients because biosimilars are not identical to biologics.
  • Generic drugmakers are taking steps to oppose or amend the state bills, which they describe as pre-emptive moves to discourage biosimilars before they reach the market, which is not expected to occur in the US for at least two years.
  • The regulatory uncertainty over biosimilars appears to be diminishing the enthusiasm for some firms for developing these drugs, as Craig A. Wheeler, CEO of Momenta Pharmaceuticals, notes that "this is a pathway that neither industry nor the FDA knows how to use."
  • Some of the bills would also require patient consent for a substitution, for the pharmacist to inform the doctor if a substitution is made and for doctors to maintain records of the change for years.
  • Opponents of the measures believe that restrictions on medicines that are declared interchangeable by the FDA are unnecessary and only serve to stifle competition.