Biosimilars were briefly (albeit unofficially) known as biogenerics, then follow-on biologics, before the current nomenclature was adopted. The U.S. FDA website defines biosimilars as “biological prescription drugs that are demonstrated to be ‘highly similar’ (biosimilar) to or ‘interchangeable’ with an FDA-approved biological product.” Yet some experts believe the designation can apply solely based on chemical similarity, approval mechanism, or a combination of chemistry and medical indication.
The 2009 biosimilars market for the U.S. and Europe is estimated at $150 million, according to Datamonitor’s recent report Pharmaceutical Key Trends 2011—Biosimilar Market Overview. But with 30 biologics—with annual sales of $51 billion—losing patent protection before 2015, biosimilars should experience explosive growth with sales reaching $3.7 billion by 2015. Worldwide revenues for all biologics in 2008 were $123 billion.
Although this article is about biosimilars, it is useful to discuss them within the context of the gamut of follow-on biologics (here meant descriptively and intuitively, not in any official sense) that include biobetters (a.k.a., biosuperiors) and innovator biologics that in some way resemble an approved molecule.
For our purposes, biosimilars are drugs that strive to be identical in every measurable way to an approved biological. Next-generation improvements in drug properties (e.g., pharmacokinetic advantages through PEGylation or drug-device combinations) are biobetters, while changes resulting in altered drug function result in new biological entities, or innovative drugs.
The relative significance of the three follow-on classes becomes apparent when global pharmaceutical markets are divided into emerging (“pharmerging”), European-style single-payer, and the more complex U.S. system.
In emerging markets (e.g., Russia, South America, Eastern Europe), where consumers generally pay for their own medicines, biosimilars will dominate based on price. In these nations, loyalty to domestic manufacturers and brands combined with high commercial entry barriers suggest that breaking in will likely follow a branded-generic model that relies heavily on manufacturing and distribution partnerships.
Western Europe has already shown its accommodation to biosimilars by approving 14 of them, compared with just four in the U.S. Here the operative term is value. Biobetters and innovative biologicals must demonstrate some combination of testable patient benefit and pricing advantages.
Not surprisingly, and despite the paucity of stateside approvals, the U.S. has become the testing ground for discovery, manufacturing, regulatory approval, and reimbursement for the three follow-on classes, particularly biosimilars. Not everyone agrees that success will be automatic.