The evolution of the European Union"s approach to regulating biosimilars is a potential model upon which we can design a process that facilitates access to biosimilars while providing assurances of safety.

The 1984 Hatch-Waxman Act created a streamlined path for generic drugs to reach the market after pioneer drug patents expire. The result has been the most vigorous and competitive generic drug market in the world, but the Hatch-Waxman Act does not apply to most biologics. Isolated from a variety of...

Legislation to expose today's biologics to easier competition, after legitimate patents have expired, is going to accelerate development of improved products.

The new health care law will create a policy limbo that is likely to persist for decades, increasing uncertainty, ultimately discouraging investment and scientific risk-taking.

Establishing a pathway for biogeneric competition is an important but challenging task facing lawmakers today.

In patent politics there is more at stake than money.

Alberta's funding of carbon-capture technology is taxpayer-funded publicity for private companies.

As Congress considers legislation that would allow imitative biological products, known as "biosimilars," to rely on the safety and efficacy data of original innovators, it must ensure that any provisions passed will foster, not stifle, discovery.