TPP Agreement would reduce data exclusivity for pharma, bio

Trade partners negotiating the Trans-Pacific Partnership trade deal have reached an agreement, although it may be months, or even more than a year, before the Obama Administration submits the deal to Congress for approval. The agreement details have not been officially released, and likely will not be for at least a month, perhaps longer.

The New York Times, POLITICO and others are reporting that, in order to reach an agreement, the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently, the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years.

A leaked version of the TPP from WikiLeaks, if indeed an accurate representation of the TPP, confirms that data exclusivity for 5 years was agreed to by the Obama Administration. Specifically, Article QQ.E.16.1(a), which relates to data protection for pharmaceutical test data, reads as follows:

If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar product on the basis of:

(i) that information; or

(ii) the marketing approval granted to the person who submitted such information

for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

(emphasis added).

Article QQ.E.20(1) on biologics reads:

With regard to protecting new biologics, a Party shall either:

(a)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic62,63, provide effective market protection through the implementation of Article QQ.E.16.1 and Article QQ.E.16.3 mutatis mutandis for a period of at least 8 years from the date of first marketing approval of that product in that Party; or alternatively

(b)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:

Without Prejudice

(i)  through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;

(ii)  through other measures; and

(iii)  recognizing that market circumstances also contribute to effective market protection

to deliver a comparable outcome in the market.

(emphasis added).

Thus, the TPP will offer different data exclusivity for pharmaceuticals (at least five years) and biologics (at least 5 years, but perhaps as long as 8 years).

While the term of data exclusivity is not one and the same with the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

According to POLITICO, some countries viewed 12 years of data protection as prohibitively expensive as they search for ways to offer such treatments to their population. The U.S. government, specifically the Obama Administration, has also long wanted a more limited term for data exclusivity.

Stay tuned as the official agreement is released and debate in Congress begins.

Implementing the Biologics Price Competition and Innovation Act?

Alexandra McTague, of DLA Piper, sent in this article discussing whether the final rules the FDA implements for follow-on biologics will actually end the debate surrounding the Biologics Price Competition and Innovation ACT (BPCIA).

The vigorous debate over the Biologics Price Competition and Innovation Act (BPCIA), which aims to provide an expedited approval framework for follow-on biologics, will likely inform the final rules the FDA implements, and those rules will determine the business strategies of innovator companies and the extent to which generic companies use the BPCIA.

Biosimilars vs. interchangeable biologics

Under the BPCIA, generic biologics can be characterized as “biosimilar” to or “interchangeable” with innovator products. Both require clinical studies for approval, with interchangeability requiring a higher showing. Only those follow-on biologics designated as “interchangeable” can be automatically substituted by a pharmacy for the innovator’s product. As a result, generic companies will have to market biosimilars to boost prescriptions and sales. Thus, when seeking approval, generic companies will weigh the cost of marketing biosimilars against the cost of the yet-to-be-determined clinical testing requirements for interchangeables. If those requirements are too onerous, the generic company may instead choose to pursue a Biologic License Application (BLA), which has the benefit of circumventing the innovator company’s marketing exclusivity. (more…)