FDA and the European Medicines Agency are continuing to harmonize their requirements for biosimilar approvals to enable companies to submit one package of data to both agencies.

Janice Soreth, deputy director of FDA's Europe Office, discussed the collaboration between FDA and EMA at Elsevier Business Intelligence's Pharmaceutical Strategic Alliances Conference, held in New York City Sept. 21-23. She noted that the two agencies have about 55 interactions every month, including meetings, teleconferences and document exchanges.

Companies "come to each of our agencies" to say they are about to go into a Phase II or Phase III development program and that they would like to develop "one package that satisfies requirements for both agencies," Soreth stated. "More often than not we can achieve that."

The agencies have previously collaborated on issues of mutual interest through "clusters," topic-specific groups. They recently formed a biosimilars cluster, which held its first meeting in July.

Soreth said that going forward the group will discuss guidances that come out of FDA, revisions of the European Union's umbrella biosimilars guideline, the regulatory legal framework in which they operate, global development and sourcing of reference products, pharmacovigilance, naming and traceability to specific products and the opportunity for providing parallel scientific advice.

"Fingers crossed getting both agencies on board with a single program of development," Soreth said.

Boehringer Bounds Into The Field

Regulatory harmonization is of increasing importance to big pharma and generics companies as they line up to make big bets on biosimilars (Also see "And Now For The Real Biosimilar Opportunity: Antibodies And Complex Biologics" - Pink Sheet, 27 June, 2011.).

Boehringer Ingelheim, for example, is the latest entrant into the race, following in the footsteps of several big pharmas, such as Merck & Co and Pfizer Inc. The privately held German pharma announced Sept. 26 that it would establish a separate business for the development and commercialization of its own biosimilars.

At first glance, the effort makes sense, given that there's no drug discovery required, and big companies like Boehringer will likely have an advantage, given the emphasis on manufacturing and processing innovation and a requisite experience with the regulatory and commercial landscape.

Some observers don't believe that large size will necessarily convey a mortality advantage among biosimilar competitors, however (Also see "Biosimilar Players Will Be Manufacturers Large And Small, Analyst Predicts" - Pink Sheet, 26 September, 2011.).

Regardless, Boehringer and other firms that want to compete in the biosimilars space will have their work cut out for them, given the complexity of the process, uncertainty of the regulatory landscape, and evolution of the business model.

Shift From Product Specific Requirements

Despite strong desires from regulators and the regulated alike, convergence may only be able to go so far, FDA's Soreth said.

One major difference between the U.S. and European pathway is the latter's requirement for clinical data on biosimilars. The U.S. pathway laid out in the health care reform law enacted last year states that biosimilarity to a reference product must be based on analytical, animal and clinical studies but FDA has the ability to waive clinical data.

"I don't know for a fact that my European colleagues are going to look at their current guidance that requires clinical data and roll it back," Soreth said.

But she said EMA's recent guidance on monoclonal antibodies indicates there is a shift from product specific requirements "toward totality of evidence and really nailing down the analytics and having that as the driver for the amount of clinical data that might need to be in a package."

What FDA Is Thinking And Doing

FDA has said it plans to issue its guidance on biosimilars by the end of the year and Soreth reiterated that it could be released in the next few weeks or even days. She said the first guidance would be an "overarching umbrella scientific considerations type of guidance."

She cited the perspective piece that the agency published in the New England Journal of Medicine in August as the best indication of FDA's current thinking on the issue.

FDA officials wrote that they intended to use a "totality of the evidence" method in assessing biosimilar applications (Also see "FDA's Biosimilar Strategy Will Rely On "Fingerprint" Technology To Limit Trials" - Pink Sheet, 4 August, 2011.).

Companies are continuing to seek out meetings with FDA officials to get input on their development programs.

Soreth noted that as of a month-and-a-half ago FDA had received 23 pre-IND meeting requests for proposed biosimilar products referencing nine or 10 reference products and had held 17 or 18 pre-IND meetings.

As of the end of May, eight pre-IND and IND applications for biosimilar products had been submitted to the Division of Therapeutic Proteins in CDER's Office of Biotechnology Products (Also see "Biosimilars: Eight Is Already More Than Enough For FDA" - Pink Sheet, 1 June, 2011.).

- Brenda Sandburg (b.sandburg@elsevier.com)

FDA, EMA Seek Biosimilar Pathway Convergence

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