Biosimilar Drugs Gaining Traction with the FDA

Ethan Mobley, MJLST Staff Member

Recently, an FDA-commissioned panel recommended the Administration approve a cancer fighting drug developed by Novartis called EP2006. The recommendation is significant because if the FDA follows the panel’s advice and approves the drug, it will be the first time the FDA has approved a “biosimilar” drug under the Biologics Price Competition and Innovation Act (BPCI Act). A biosimilar drug is a drug that is “interchangeable” with or “highly-similar” to a biological drug already licensed by the FDA. In the words of the FDA, “[a] biological product may be demonstrated to be ‘biosimilar’ if data show that the product is ‘highly similar’ to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.” Interestingly, a biosimilar drug is not considered to be a generic version of its already-approved counterpart– only bioequivalent drugs could be generics. Nonetheless, biosimilar drugs are still desirable for consumers because they are subject to an expedited approval process compared to their already-approved counterpart. Such drugs would be readily substitutable by a pharmacist without requiring the prescriber’s permission.

In this case, the panel advised the FDA that EP2006 is biosimilar to Amgen’s medication, Nuopogen (filgrastim), which is used to boost white-blood cell production in the body. Unfortunately, Neupogen is predictably expensive. But, introduction of EP2006 into the market would make cancer-fighting medication more price-accessible for many patients. Such a decrease in price would necessarily follow from increased competition for a white blood cell-producing drug and the reduced development costs of EP2006 attributable to the expedited approval process under the BPCI Act. Ideally, a groundbreaking approval of EP2006 under the BPCI Act would also pave the way for other price-accessible medication meant to treat all sorts of ailments.

Driving Under the Influence: Recent Legal Developments in Cellulosic Ethanol Industry

Ke M. Huang, MJLST Lead Articles Editor

As a second-year law student, I met an energy law attorney who told me that sometimes his job felt like mediating between two parents. Two parents butting heads.

The more recent legal developments in the cellulosic ethanol industry since the publication of my student note in the Volume 15, Issue 2 of the Minnesota Journal of Law, Science & Technology echo the words of the attorney I met. In the note–published in Spring 2014 and entitled A Spoonful of Sugarcane Ethanol–I argue that the U.S. should enact tax benefits to spur cellulosic ethanol based on existing Brazilian tax benefits for sugarcane ethanol. Ethanol, or ethyl alcohol, is a fuel fermented from renewable resources. In the case of cellulosic ethanol, the resource is vegetative and yard waste; in the case of sugarcane ethanol, the resource is sugarcane juice.

Unlike the note, which focuses on tax benefits, the recent developments in the cellulosic ethanol industry center on blending mandates, both in the U.S. and Brazil. Under these mandates, motor fuel–which contains mostly gasoline–must be blended with a certain amount of ethanol. The U.S. motor fuel mandate is the Renewable Fuel Standard (RFS). RFS, which generally requires the petroleum industry to blend in motor fuel specific amounts for cellulosic ethanol, was already subject to litigation in American Petroleum Institute v. EPA, 706 F.3d 474 (D.C. Cir. 2013). However, the concerned industries of that case, primarily the petroleum industry and the cellulosic ethanol industry, continue to disagree. Broadly speaking, as further elaborated in this Bloomberg BNA blog entry, the petroleum industry takes the position that the RFS is unworkable. To much the vexation of the cellulosic ethanol industry. What makes the recent development more interesting is that, since early 2014, the cellulosic ethanol production seemed to have increased. Extending the metaphor of fighting parents, it is as if the ethanol parent continues to grasp the motor fuel teen, a teen that has grown bulkier in size, when the petroleum parent is ready to send the teen off to college.

In Brazil, a similar “family tale” ensues. In late 2014, Brazilian President Dilma Rousseff signed the legislation to increase Brazil’s blending percentage of ethanol from 25% to 27.5%. Still, the semi-public petroleum producer Petrobras expressed concern that, before the change in the mandate can be put in effect, more study is needed. These articles further explain these events (1)(2). As such, in this “family,” the parents are at a deadlock.

On a more serious tone, as I reread my student note, I would like to make two corrections. I apologize for the misspelling of Ms. Ruilin Li’s name on page 1117, and for the missing infra notations on page 11141 (notes 218 to 221).