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Pharmacy groups submit recommendations to FDA as agency finalizes draft guidance for biosimilars

BY Allison Cerra

WASHINGTON — As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

The FDA is working to implement the Biologics Price Competition and Innovation Act — which was enacted as part of the Affordable Care Act — and is "designed to create an approval pathway for biosimilar and interchangeable biological products while preserving the incentives that have fueled the development of these medicines."

The American Pharmacists Association, National Association of Chain Drug Stores and the National Community Pharmacists Association sent a joint letter to the FDA, requesting the agency to consider the following recommendations:

  • Biosimilar products should maintain the same name as their reference biologic counterparts to help prevent confusion. The use of suffixes should be avoided as well;

  • Pharmacists should be able to automatically substitute biosimilar products for their biologic reference product, assuming the FDA deems interchangeability between products;

  • The FDA should provide further guidance regarding whether biosimilar medicines will be determined to be interchangeable with their reference products, how pharmacists can assess appropriateness of substitution for individual patients, labeling provisions for manufacturers, and prescribing standards for physicians; and

  • An interchangeability reference list should be developed by the FDA, something similar to the current Orange Book for generics, to assist health care providers in managing these prescription orders.

“Pharmacists are the most accessible healthcare professionals and recommending generic alternatives is a standard pharmacy practice,” the APhA, NACDS and NCPA said in their letter to the FDA. “Allowing pharmacists to perform fully within their scope of practice by permitting automatic substitution of cost-effective biologic and specialty medications increases availability, thereby greatly benefitting the entire healthcare system and the patients it serves. Our organizations recognize the need for education and training of health care providers on biosimilars. Our organizations are willing to work with FDA and other stakeholders to help develop and provide education to pharmacists."


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A.SCHAFER says:
Jun-07-2012 04:19 pm

Good article, interesting. ISR recently authored a report on what US Pharmacists think about several topics regarding Biosimilars, including pharmacy-level substitution. Most pharmacists did not have a very solid understanding of Biosimilars and many did not agree with Pharmacy-level substitution. For more, please visit: http://www.isrreports.com/industry-reports/biosimilars-from-the-pharmacy

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Kellogg’s completes Pringles acquisition

BY Allison Cerra

BATTLE CREEK, Mich. — Kellogg’s announced that it has completed its acquisition of Procter & Gamble’s Pringles business, a deal valued at nearly $2.7 billion.

The transaction, which was first announced in mid-February, further strengthens Kellogg’s competitive position in global snacks as it nearly triples the size of the company’s international snacks business, with Pringles sales totaling $1.5 billion across more than 140 countries.

As previously reported, P&G initially inked an agreement with Diamond Foods through which Diamond Foods would acquire Pringles for $2.35 billion. The deal was delayed "to allow Diamond Foods to complete an accounting investigation." After the deal fell through, the P&G-Kellogg’s deal was announced.

"In Pringles, Kellogg has acquired a terrific business, with exceptional employees, world-class manufacturing facilities, iconic brand awareness, and a tremendous platform for growth," Kellogg’s president and CEO John Bryant said. "The addition of Pringles to our portfolio significantly advances the company’s strategic goal of building a global snacks business on par with our global cereal business, and expanding our global footprint."

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House passes PDUFA bill 387 to 5

BY Michael Johnsen

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

The House’s FDA Reform Act of 2012 (H.R. 5651) includes reforms to the FDA’s current evaluation and approval processes for prescription drugs and medical devices that makes the process more efficient, transparent and consistent, noted bill sponsor Fred Upton, R-Mich. Under current law, U.S. companies have been put at a competitive disadvantage with overseas manufacturers, who already benefit from a more streamlined approval process, Upton noted in a statement released Wednesday.

Upton expected a final bill to reach the president’s desk by early summer.

H.R. 5651 reauthorizes for five years the Prescription Drug User Fee Act and the Medical Device User Fee Act. Under these user fee agreements, the FDA collects fees directly from medical manufacturers to fund the agency’s drug and device approval processes. The legislation also establishes new user fee programs for generic drugs and biosimilars, and encourages the development of treatment options for children with rare diseases.

Lawmakers must reconcile differences in the bills, such as dates for the FDA to comply with certain provisions and language in the Senate’s version that would require more scrutiny for some new devices.

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