GPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation

By James C. Shehan –

The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs.  In a joint letter to the European Commission’s Trade Commissioner and the US Trade Representative, GPhA and the European Generic medicines Association (“EGA”) made recommendations that “regulatory convergence” be included in the negotiations for the Transatlantic Trade and Investment Partnership (“TTIP”).  TTIP is a prospective trade agreement that is currently being negotiated between the European Union and the United States.  It is intended to remove trade barriers in a wide range of economic sectors to make it easier to buy and sell goods and services between the EU and the US.

The GPhA/EGA letter makes five specific recommendations for inclusion in TTIP:

1. Implement a single development and approval pathway for biosimilars, via adoption of appropriate  guidelines/guidances by both regulators and facilitated by work of the existing FDA-EMA “cluster” group that currently exchanges information on biosimilars; 
2. Implement a single development and approval pathway for traditional generic medicines, again via adoption of appropriate  guidelines/guidances by both regulators and facilitated by establishment of a new FDA-EMA cluster that would meet regularly to exchange information; 
3. Mutually recognize cGMP inspections; 
4. Allow manufacturers to make generic and biosimilar products during the periods of US patent term extension and EU Supplementary Protection Certificates, so that (i) generic products made in the US and the EU can be exported for sale to the rest of the world prior to patent expiration and (ii) generic products can launch in the US and the EU immediately after patent expiration; and
5. Reject any suggestion to harmonize the US and EU  intellectual property regimes, specifically by rejecting any alignment of the periods of data and market exclusivity enjoyed by innovators.

It’s worth noting that in the context of TTIP, there is a difference between “convergence” and “harmonization.” Convergence refers to making separate systems work more smoothly together, while harmonization refers to adoption of the same system.  The European Commission’s website specifically notes that harmonization is “not on the agenda” for TTIP.  There may be some difficulties in squaring “no harmonization” with a “single development and approval pathway.”   

Interestingly, the GPhA/EGA letter is silent on one of most robustly debated biosimilar topics – how those products will be named in the US (see our previous posts here, here, and here).  Under the EU system, biosimilar products have names that are distinguishable from innovator reference product, either by use of a unique brand name or by attaching the company name to the generic name of the active ingredient.  GPhA has opposed proposals to require US biosimilars to have distinguishable nonproprietary names.  At a January meeting with FDA, however, GPhA, indicated that it may be willing to accept attaching a company name to the non-proprietary name, provided that the requirement also applies to brand name companies. GPhA also indicated at that meeting that its members would commit to the using brand names, even though FDA may not have the authority to require brand names.    

TTIP negotiators hope to finish their work in 2015.