The world’s largest two markets for prescription medicines remain a study in contrasts: The European Medicines Agency authorizes 11 biosimilar drugs for market in the nations comprising the EU. Meanwhile in the U.S., the FDA continues to ponder draft guidances for how the agency will evaluate biosimilars.
Those guidances, released last year, left numerous questions unanswered: How similar should the near-copies be to their innovator drugs? How should drugmakers demonstrate the safety of their products? How should interchangeability of biosimilars to innovator products be determined? How should biosimilars be named and labeled? Biopharma companies are closely watching what FDA does since patents for 12 blockbuster biologic compounds generating a combined $67 billion in sales will expire by 2020, according to the Generics and Biosimilars Initiative. Biopharma companies don’t want to be left behind as the biosimilar segment grows—from $172 million in 2010 to an estimated $3.927 billion by 2017, according to Frost & Sullivan.
EMA defines biosimilars as “similar to a biological medicine that has already been authorized, the so-called reference medicinal product.” FDA has proposed using slightly stricter wording, declaring that, in order to be considered a biosimilar, the biological product must be “highly similar to the reference product notwithstanding minor differences in clinically inactive components.” By minor differences, the agency states that there should be no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
As reported in this space last year, “EMA’s development of solid guidelines almost a decade ago followed by specific rules for different drug classes helps explain why Europe is much further along than the U.S. in bringing biosimilars to market.” Little has changed since then.
You've already seen a list of the top 20 best-selling drugs approved and launched during 2012; now, following is a list of 10 drugs for which biosimilars are either being marketed somewhere in the world, are in clinical development, or in some cases, whose development was ended within the past year. Drugs are listed by original brand name (generic name), followed by a list of drug developers with a brief summary of the status of their biosimilar, and its name where known; the nature of the drug and its indication; its 2012 sales (and the original drug’s maker or makers); and the drug’s patent status in the U.S. and EU.