One of the impediments to a reasonable public dialogue regarding the creation of a pathway for the approval of biosimilars has been the deluge of misinformation. It is difficult to choose where to begin in correcting the numerous falsehoods in a recent guest editorial in the New York Times (“Biologics Boondoggle”; 3/8/10).
To start, the authors claim that the provisions in the House and Senate health care reform bills would “discourage the development and significantly delay the approval of generic biologics.” There is currently no pathway for the approval of biosimilars. The legislation would allow, for the first time, biosimilar manufacturers to rely on the safety and efficacy of the innovator biologics to secure abbreviated approval of competitive products.
The authors also confuse the facts when claiming that 12 years of data protection for innovator biologics would give biologics “seven more years of market exclusivity than conventional drugs have.” This is blatantly incorrect. Duke University Professor Henry Grabowski found that, due to protections in current law for traditional medicines, these small molecule pharmaceuticals are marketed in the United States for an average of 13.5 years before facing generic competition.
While the period of data protection in the Hatch-Waxman Act, which has governed the traditional drug market for nearly 30 years, is between 5 and 7.5 years, this period runs concurrent with patent protection (which can be extended up to 14 years post-approval to make up for time spent in clinical trials and awaiting approval by the Food & Drug Administration (FDA)). And the innovator’s patents can effectively protect against generics because, under the law, those products must be identical to the innovator. Yet, as the name suggests, a biosimilar would be similar to – but not the same as – the innovator biologic, which creates an opportunity for biosimilar manufacturers to design around the innovator’s patents while still being similar enough to rely on the innovator’s safety and efficacy. In order to provide protection for biologics that is similar to what small molecule pharmaceuticals receive, a significantly longer period of data protection is needed for innovator biologics. This longer period of data protection only compensates for the greater uncertainty in patent protection, and since the two systems run concurrently, it does not give biologics any greater protection against follow-on competitors than Congress granted small molecule drugs in Hatch-Waxman.
The authors also make blatantly false claims about so-called “evergreening.” The legislation would not allow an innovator biologic to receive any extension of the period of data protection, except for six months for conducting FDA-requested pediatric studies. If the innovator biologic manufacturer creates a new product, it would need to complete a full set of clinical trials and seek FDA approval. In that case, the innovator would receive data protection only with respect to this new product. Biosimilar manufacturers would still have the opportunity to seek abbreviated approval based on the original product. It is not in the interest of patients todiscourage manufacturers from developing new products to better address their needs, and this is only possible if the lawallows the manufacturers to recoup the costs of research, development and clinical trials.
Throughout the editorial, the authors refer to market exclusivity and monopolies neither of which exist now nor would exist if the provisions contained in the House and Senate health care reform legislation become law. Even without a pathway for biosimilars, innovator biologic companies develop products to treat the same diseases and compete in the marketplace. Insulin and human growth hormones are two examples, where currently multiple innovative products compete. Manufacturers would continue to be able to develop new products, conduct clinical trials and seek FDA approval. They only need to wait 12 years if they want to piggyback off the innovators’ massive investment in proprietary safety and efficacy data.
Fortunately, the vast majority of the House and Senate had their facts straight. The biosimilar provisions were approved by overwhelming bipartisan majorities in the committees of jurisdiction in the House and Senate and included in the final versions of health care reform legislation in both Chambers.
The Members of the House and Senate who voted for the biosimilar provisions understand that providing a shorter period of data exclusivity would result in minimal additional savings for the government and for patients, but would discourage the investment necessary to research and develop new therapies. We can have today’s drugs at slightly lower prices tomorrow, but the cost – a vast reduction in the number of new therapies to treat cancer, Parkinson’s, Alzheimer’s and many rare diseases – is hardly justified by the minimal savings.
For more thoughtful commentary on the New York Times guest editorial, check out Kevin Noonan’s recent post on the Patent Docs blog.