BIOSIMILARS
David Cornwell and Kevin McCabe describe the complex process for obtaining FDA approval
for generic and biosimilar drugs, and managing patent disputes with approved companies.
In 1984, 19 percent of prescription drugs sold were generic. In stark contrast, some accounts estimate that up to 75 percent of all prescription drugs sold in the United States 25 years later were generic. Understandably, the desire for generic drugs is fuelled by consumer demand and simple economics—with competition comes price reduction. However, innovator companies realise that drug pricing must pay for the cost of both basic drug discovery and the cost of obtaining approval from the Food and Drug Administration (FDA). T e innovator drug companies therefore continue to rely on an eff ective patent system to ensure that generic companies cannot easily enter the marketplace.
US ANDA legislation
T e Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) was enacted to increase the availability of generic drugs to consumers. While generics are more readily available, the act has caused delays in these drugs entering the market.
T e FDA compiles a list of approved drugs in Approved Drug Products with T erapeutic Equivalence Evaluations, known as the ‘Orange Book’. When required patent information is submitted for a new drug application (NDA), the patent information is included in the Orange Book.
T e abbreviated new drug application (ANDA) process allows a party to obtain FDA approval for a generic drug without clinical trials if the drug is a bioequivalent of an FDA-approved drug. To piggyback off of the NDA approval, the ANDA applicant must make a certifi cation regarding the patents listed in the Orange Book. Oſt en this is a certifi cation that the patent is either invalid, unenforceable or will not be infringed by the ANDA applicant.
Aſt er being notifi ed of this certifi cation, an NDA holder has the right to sue the ANDA applicant for patent infringement even though the ANDA applicant has not yet commercialised the generic drug. T e patent infringement case is tried by a judge and the remedy is an injunction (not monetary damages).
If the NDA holder fi les a patent suit within 45 days of the certifi cation, an automatic stay provision is triggered so that the ANDA application will not generally be approved for 30 months. T e fi rst company seeking ANDA approval gets a 180-day market advantage over subsequent fi lers.
US biosimilars legislation
In spring 2010, President Obama signed healthcare reform legislation, which included for the fi rst time an abbreviated approval path for generic versions of biological medicines (biosimilars). It is oſt en said that the two things that the public ought never to see being made are sausage and law. In the case of the biosimilar approval process legislation, Congress tried to balance various divergent interests. As a result, the law is full of snouts and feet and tails.
T e legislation establishes two categories of generic biological medicines—those that are ‘biosimilar’ to the approved medicine and those that are ‘interchangeable’. To be biosimilar, the drug must be highly similar to the reference drug, notwithstanding minor diff erences in clinically inactive components, and must have no meaningful diff erences in safety and potency. To be interchangeable, the drug must have the same clinical result in any given patient, and it must be possible to switch back and forth between the reference drug and the drug seeking approval without risk to a patient. Biological medicines that are ‘interchangeable’ qualify for an exclusivity period of up to one year aſt er marketing of the fi rst approved product.
www.worldipreview.com
World Intellectual Property Review November/December 2010
27
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iStockphoto.com / Fotografi aBasica
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