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Biopharma Speeding Down New Biosimilar Pathway

By Mari Serebrov
Washington Editor

WASHINGTON – Companies chasing down biosimilars are not letting the lack of guidance slow them down.

Nine investigational new drug applications (INDs) for biosimilars already have been submitted to the FDA, and the agency is anticipating its first 351(k) application before the end of the year, Rachel Sherman, associate director for medical policy at the FDA's drug center, said Friday at a media briefing.

By then, the agency should have released its first draft guidance on the new regulatory pathway created by the 2010 Affordable Care Act. That guidance, which was promised last year, is in the final stages of agency review and will be released "as quickly as possible," Sherman said. (See BioWorld Today, July 26, 2011, and BioWorld Insight, Jan. 4, 2012.)

When asked why the guidance has been delayed, Sherman said, "That's a really hard question to answer."

That's part of the problem. The guidance must deal with a lot of tough questions, as the biosimilar path is a totally new regulatory paradigm. Because of the need for guidance, the initial document will target the highest priority issues, Sherman said.

Once the guidance is out, there is still likely to be uncertainty as the FDA will need to review biosimilars on a product-by-product basis. Under the law that created the new path, the agency is required to look at data from analytical, animal and clinical studies in reviewing a biosimilar application. But it has the discretion to determine if those elements are all necessary for a specific product.

Because of the complexity of biologics, Sherman expects immunogenicity studies will always be required. Otherwise, she said, the agency may use a variety of approaches.

One approach would be to take the approval in steps, with the data from each new step dictating what is needed next, she said. Another approach would be to look at the totality of the evidence.

Regardless of how the FDA approaches a review, it will have a standard 10-month clock to consider a biosimilar application, which means the first approved biosimilar could potentially be on the U.S. market late next year – if the agency doesn't stop the clock.

Even without guidance, would-be biosimilar makers are getting advice from the FDA. To date, the agency has received 35 requests for pre-IND meetings on 11 referenced biologics. It has held 21 of those meetings, Sherman said.

Patent Issues Shadow Personalized Medicine

Regulatory uncertainty may be casting a greater shadow over the future of personalized medicine.

Not only is the FDA drawing new question marks as it asserts more authority over some diagnostic tests and toughens its approval process, but Congress has signaled that the final word has yet to be spoken on the patentability of some diagnostic claims vital to personalizing medicine.

That signal is in the guise of a report on genetic diagnostics mandated by the America Invents Act (AIA), Antoinette Konski, a partner with Foley & Lardner LLP, told BioWorld Today. To gather information for the report, the Patent and Trademark Office (PTO) is conducting two public meetings, one Feb. 16 in Alexandria, Va., and one March 9 in San Diego. (See BioWorld Today, Jan. 25, 2012.)

The AIA doesn't indicate what the report is for, but Konski said, given the questions the PTO is asking, the biopharma industry needs to comment. Ranging from costs to the availability of second-opinion testing, "these are odd questions to put to the Patent Office to answer," she added, as they deal with health care and economic issues rather than patentability.

The questions mirror issues raised by the American Civil Liberties Union (ACLU) in its challenge of Myriad Genetics Inc.'s patents on the BRCA1 and BRCA2 genes, Konski noted. Mutations on those genes are responsible for most cases of hereditary breast and ovarian cancers. (See BioWorld Today, Dec. 13, 2010, and April 5, 2011.)

After the Court of Appeals for the Federal Circuit rendered a split decision in Myriad, which has been appealed to the Supreme Court, the ACLU said, "Myriad's monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allows Myriad to charge a high price for its tests." (See BioWorld Today, Aug. 2, 2011, and Dec. 9, 2011.)

The requirement for the report on genetic diagnostics was a congressional compromise. An early version of the bill included a safe harbor for second-opinion tests, Konski said.

OIG: FDA Oversight an Issue

One of the top management challenges at the Department of Health and Human Services last year was the FDA's oversight of the approval, safety and marketing of drugs and medical devices, according to a new report by the department's Office of Inspector General (OIG).

Citing vulnerabilities in the FDA's ability to ensure the timeliness of drug reviews, the prevention of off-label marketing and the safety of clinical trial subjects, OIG expressed concern that the agency's new authorities to approve biosimilars could make matters worse.

The "FDA will need to develop a plan to implement these new authorities without exacerbating its backlog for drug approvals," OIG said.

The report acknowledged progress the agency has made to resolve the problems, but OIG advised the FDA to focus on reducing off-label promotion, since it can endanger patients and increase fraudulent claims to federal health care programs.