Rapid Rise in IND’s for Biosimilars

By Bob Bohrer
[Cross-posted on Pharmaceutical Policy.]

According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face many years of clinical trials and long odds against approval (DiMasi et al estimated the approval rate at sixteen percent to nineteen percent). However in this “a little brave” and “a little new” world of biosimilar development, clinical development programs are likely to be much shorter in duration than development programs for new drugs or innovator biologics, and the success rates are likely to be very high, as I indicated in a pharmaceuticalpolicy.blogspot.com post of May 19th, 2014. The DiMasi study referenced above estimated the large molecule success rate at thirty-two percent; and, biosimilars are not only within that large molecule category, they are copies of drugs that have already been shown to be reasonably safe and effective. So it is very likely that we will see filings for the approval of more than twenty biosimilars in the next three years.

It will be very interesting to watch the rapidly developing biosimilar marketplace.

Congressmen Express Concern About Proposed Changes to Generic Drug Labeling Rules

By Bob Bohrer

I have previously posted on pharmaceuticalpolicy.blogspot.com about the FDA’s proposed change to the rules for generic drug labels and an estimate of the liability costs that might be incurred by the generic drug industry as a result of the proposed change.  The Generic Pharmaceutical Manufactuer’s Association lobbying efforts appear to have motivated Congressmen Steve Israel (D-NY) and Timothy Bishop (D-NY) to draft a letter to the FDA requesting changes to the proposed rule.  A copy of the Congressmen’s letter to the FDA can be downloaded through this link.

Pharmaceutical Pricing– The Story That Just Keeps Going

By Bob Bohrer

Cross-post from Pharmaceutical Policy

After last week’s foray into patents and pharmaceutical policy, which is perhaps the most technical and specialized area of pharmaceutical policy, I will return to the never-ending story of pharmaceutical prices and the controversy over Sovaldi, Gilead’s break-through Hepatitis C drug. Sovaldi has a “sticker price” of $84,000 for a 12-week course of treatment, at the end of which 90% or more of patients would be expected to be cured. Since Sovaldi is a pill that is given once a day, the 12-weeks of treatment means that there are 84 daily doses. The math is easy, even if the price, unlike the pill, is hard to swallow–$1,000 per pill. The drug has been a huge financial success for Gilead, which reported $2.274 billion in sales in just the first quarter of 2014.   However, the backlash has been equally huge. In a rare display of bipartisanship in Washington, Senator Ron Wyden (D.-Ore), the Chair of the Senate Finance Committee and Senator Chuck Grassley (R.-Iowa), the Ranking Member of the Finance Committee, sent a demand for information concerning the development costs of Sovaldi and Gilead’s pricing decision. However, even more than the investigation by two senior senators, the impetus for today’s post came from the blog RxObserver, which featured a post entitled Sovaldi: A Poster Child for Predatory Pricing [sic]. Before discussing the epithet “predatory pricing,” the perspective of RxObserver requires a bit of explanation. RxObserver is a site that primarily provides the views of pharmaceutical benefit managers (PBMs), or as the blog itself states its purpose: “the Clearinghouse of the Future for Pharmacy Benefits.” It is, in general, a very high-quality blog, with an editorial staff composed primarily of well-recognized academic and government experts in health care policy. I regularly read it and find it useful, although I was taken aback by that “predatory” epithet. Continue reading

Profits or Drugs?

By Bob Bohrer

Cross-post from Pharmaceutical Policy

There were two stories in The New York Times that, although not directly related, are the basis for today’s post. The first, by Andrew Ross Sorkin, Do Drug Companies Make Drugs, or Money?,appeared in the Business Section on page B1 on June 3, 2014. The second, by Andrew Pollock, New System for Treating Cancer Seen as Hopeful, appeared on the same page of The New York Times on the same day. Sorkin’s provocatively titled article focused on Valeant Pharmaceutical International’s takeover bid for Allergan and on Valeant’s strategy, which Sorkin characterized as buying pharmaceutical companies with revenues produced by active and successful pharmaceutical research programs and then increasing profits by cutting back on R&D. Sorkin’s article, as the title indicated, posited a tension between focusing on rewarding investors with increased profits and investing in the development of new and innovative therapies. My purpose in highlighting Sorkin’s article alongside Pollock’s is not to take issue with Sorkin’s analysis of Valeant’s business strategy, but to respond to the article’s title question.  Continue reading

Introducing New Blogger Bob Bohrer

bohrerBob Bohrer is a Professor of Law at California Western School of Law.  Having joined the faculty in 1982, Bob was one of the first full-time law teachers in the United States to concentrate on the emerging area of biotechnology law. His research is focused on the way in which drug development is influenced by a number of areas of law, including FDA approval, patent law, insurance and reimbursement, and the First Amendment commercial speech doctrine.

Bob is Chair Elect of the Biolaw Section of the Association of American Law Schools.  Continue reading