Biotech Manufacturers Face Competition from "Similar" Follow-Ons - New legislation offers extended data exclusivity to innovators in exchange for a flexible approval process - BioPharm International


Biotech Manufacturers Face Competition from "Similar" Follow-Ons
New legislation offers extended data exclusivity to innovators in exchange for a flexible approval process

BioPharm International
Volume 20, Issue 8

In finalizing the bill, Sen. Edward Kennedy (D-MA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, clarified that a reference product can have only one 12-year exclusivity period. Such exclusivity starts the day FDA approves the product for market, and innovators can't add more years by developing new formulations or dosage forms, adding new indications or conducting pediatric studies. The exclusivity applies only to a biologic that is comparable to a new chemical entity for drugs, and not to a slightly different version of an existing treatment.

Kennedy touted the Senate compromise as a way to "encourage the innovation that leads to these new medical miracles," as well as to ensure that they are affordable for patients. Senators Orrin Hatch (R-UT), Mike Enzi (R-Wyo), ranking Republican on the HELP committee, and Hillary Clinton (D-NY) all signed off on the measure, making partisan changes difficult.

One reason for agreeing to 12 years exclusivity, said Clinton, is that many biotech therapies have been on the market long enough to be eligible immediately for follow-on competition. Amgen's anemia treatment Epogen (epoetin alfa), for example, was approved in the US in 1989, and other biotech therapies for multiple sclerosis, cancer, hepatitis C, and diabetes have or will soon exceed the exclusivity period.


The Senate bill announced in June permits generics makers to file an application for a biosimilar four years after the start of the innovator's exclusivity period, a move that triggers a multistep process designed to resolve patent issues early on. It calls for an exchange of confidential information between the follow-on firm and the innovator on manufacturing process and product characteristics to identify effective patents. It is not clear just how the system will work, and biotech firms are concerned that the follow-on firm will determine which patents can be litigated, making it harder to defend patent rights.

Congress also offers a process for developing interchangeable FOBs. But to gain approval of an FOB that pharmacists can substitute for the original product without the prescriber's okay, the follow-on maker will have to conduct clinical trials to show that the new product can be switched with the original one without any clinical differences. The legislation offers FOB sponsors a one-year data exclusivity award as an incentive to take that route.

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms. The measure calls for at least one or more clinical studies to assess immunogenicity of a follow-on, but gives FDA leeway to waive that requirement.

FDA may develop guidance for testing and developing FOBs, but generics firms don't have to wait for such guidance in order to move forward with testing and applications. Such guidance could indicate that existing science does not support follow-ons for a certain product class, but FDA could revise such a finding later on.

Follow-on applicants will start off by paying user fees on applications while FDA assesses the costs of running the program and recommends changes in the fee structure. Along those lines, the FDA review division that approved the innovator will assess any follow-ons—not FDA's Office of Generic Drugs. This could encourage FDA reviewers to compare proprietary brand data when evaluating an FOB, something that innovators strongly oppose.

A provision in the Senate bill calls for the government to determine how much money the healthcare system saves from allowing follow-on biologics to come to market. A lot of interest groups have predicted huge gains from FOBs, and it will be interesting to see the results.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD 301.656.4634,

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