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Healthcare & Medical

Drawing Attention to Pharmaceutical Trends

(568 words)

Industry watchers take note: the pharmaceutical industry continues to push the envelope when it comes to innovative ways to deliver pharmaceuticals while holding down costs. One of the key pharma industry trends for 2015 is biosimilars and just as the calendar turned to the new year, the FDA approved the first one, developed by Sandoz.

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What are biosimilars?

Biosimilar therapies include active ingredients that are not exact copies of the active ingredients in the brand name drug. That also differentiates them from generic therapies.

Drugs.com reports that whereas generic therapies have a “proven bioequivalence of the active ingredient(s), plus inclusion of the same use, dosage form, strength, route of administration, and labeling” as the brand name drug, in the case of biosimilars, “a biological product may be demonstrated to be ‘biosimilar’ if data show that the product is ‘highly similar’ to an already-approved biological product.”

Is there a track record?

In a word, yes. Europeans are using biosimilars, and have been for ten years. In the U.S., however, despite the Biologics Price Competition and Innovation Act of 2009 (the BPCI Act), the FDA is just now getting around to formulating standards for the U.S., according to Drugs.com.

Sandoz owes the ease of the new FDA approval of its biosimilar, Zarzio, to the fact that it is already in use in Europe (where it is labeled Zarxio). That naturally begs the question of the FDA’s true comfort level with biosimilars not already in the market elsewhere.

The pipeline

According to PharmTech.com, Janet Woodcock, a director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research (CDER), observed that “the pharmaceutical development community is extremely busy developing biosimilars….” PharmTech notes that “there has been speculation about whether FDA will bring all biosimilar applications to advisory panels, and that now looks likely.”

Two pharmaceutical manufacturers have requested FDA approval for biosimilars already: Canada-based Apotex and South Korea’s Celltrion.

Remaining questions

In addition to awaiting the new FDA standards for biosimilars — likely to be complex based on what we’ve read about the background of the recent Sandoz approval — several other questions remain before we can predict whether this new pharma industry trend will take root:

  • Are prescribers willing to prescribe biosimilars? That may be a complex issue involving such aspects as their efficacy, cost, and patient compliance.
  • How will health insurers react to biosimilars? We might assume that the reduced costs of biosimilar therapies would make them attractive to insurers, but insurers may hold back until there is a longer track record with similar versions, not exact copies, of brand name therapies.
  • How will patients react to biosimilars? Will patient compliance in the U.S. reflect cost savings, or might there be a reticence to try this new class of therapies until they have been marketed for several years in the U.S.?

Industry watchers should applaud pharma’s efforts to continue to look for ways to improve patient treatments while holding down costs. Given their success in Europe, biosimilars may be a promising new trend for us all.


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