Mixed Results on Bill to Enable Generic Biopharmaceuticals

As my readers know, I've followed the issue of legislation to support the introduction of generic insulin and I've given this topic ongoing coverage. Past coverage has included my original post, a follow-up based on NYT coverage, the news that legislators had finally introduced legislation to permit generic biopharmaceuticals, as well as a few relevant follow-ups, including a story that a coalition of businesses' expressed their support for the bill, another story that outlined the estimated savings that generic insulin could have on the nation's healthcare budget, and finally a story that the FDA believes that simple generic biologics like insulin may require less data for approval.

Yesterday, a story was published in The Wall Street Journal that several key Senators (including both Republicans and Democrats) had reached something of a "compromise" on the "Access to Life-Saving Medicine Act" (S.623 and H.R.1038) which was described as "a breakthrough that increases the chances that a bill might become law this year". The next step would be a vote from the full Senate health committee, likely this coming week. The revised bill attempts to seek out middle ground on a number of issues, but I am still trying to assess the net effect of these changes. So far, I am somewhat troubled with several key changes.

For example, perhaps the most troubling aspect of the compromise was that the new agreement allows for the possibility of "interchangeability," meaning that the generic version of the biotech drug could potentially be automatically substituted for the original branded medicine. Understandably, the brand-name drug industry doesn't want this, and this is one area where I believe they are right. I prefer the idea of classifying it as similar enough to substitute, but only with consent of the doctor and/or patient. Using an example, a dosage of one brand of insulin does not always have the identical effect as another brand, so giving follow-on proteins a unique status would be preferable. But the news does not say it will necessarily mean they will be considered interchangeable, only that it opens that possibility, so details would still need to be hashed out by the FDA on that.

The draft bill also includes a guarantee of 4 years of exclusive sales before a generic maker can apply to sell a biosimilar, and then 12 years before a copycat version of a biotech drug can go on the market. This compromise sucks. Although the 4-year exclusivity period is shorter than the 7 years that is given to chemical drugs, the 12 year protection after the exclusivity period ends is considerably longer. As a side note, none of this technically applies to insulin. The FDA considers insulin as nothing more than a small-molecule drug akin to aspirin, so the current laws governing chemical drugs will apply. But this compromise does give brand-name manufacturers a bit more protection than they are necessarily entitled to.

The bottom line is that I encourage people to investigate what the bill revisions could mean, and if you have any concerns, express them to your Congressional representatives in the House and Senate. Remember, their job is to serve you as constituents, not necessarily drug companies who make big campaign donations.


Senators Agree on Plan To Clear Generic Versions Of Biotechnology Drugs
By Anna Wilde Mathews and Val Brickates Kennedy, The Wall Street Journal
June 23, 2007; Page A8

A key group of senators reached a deal over how to create a legal pathway for approving generic versions of biotechnology drugs, a breakthrough that increases the chances that a bill might become law this year.

The agreement, among Democratic Sens. Edward Kennedy of Massachusetts and Hillary Clinton of New York and Republicans Michael Enzi of Wyoming and Orrin Hatch of Utah, is important because the four senators represent a broad political spectrum. The next step would be a vote from the full Senate health committee, likely this coming week.

In crafting a draft bill to allow for what they call "biosimilars," or copycat versions of biotech drugs, the four lawmakers agreed to provisions important to both the generic and the biotech industries.

A landmark 1984 U.S. law that created the modern pathway for the Food and Drug Administration to approve generic drugs left out almost all biotech products. Now biotech drugs represent some of the most expensive and important medications, and some of their earliest patents are beginning to expire. Making copies of biotech drugs is harder than with older chemically derived medicines, because they come from living cells.

Sen. Kennedy pledged to try to integrate generic-biotech language into a major FDA bill that passed the Senate last month. That legislation has to become law this year in order to renew funding for the agency. However, the House hasn't yet advanced any generic-biotech legislation, leaving it unclear whether any Senate language would survive a House and Senate conference.

The new agreement allows for the possibility of "interchangeability," meaning that the generic version of the biotech drug could potentially be automatically substituted for the original branded medicine. This is valuable to generic makers because interchangeability increases the use of their products and largely spares them the cost of marketing.

But for the biotech industry, the draft bill also includes an important boon: a guarantee of four (4) years of exclusive sales before a generic maker can apply to sell a biosimilar, and 12 years before a copycat version of a biotech drug can go on the market.

The draft bill stakes out a middle ground on another issue. Biotech companies argued that Congress should require generics makers to do human studies, while the generics industry pushed for flexibility. The draft says that a biosimilar application must include a clinical study or studies but also gives the FDA the power to waive the requirement.

Separately, Novartis AG said it cleared a hurdle in its quest to market in Europe a copycat version of the biotech anemia drug sold in the U.S. as Amgen Inc.'s Epogen and Johnson & Johnson's Procrit. A European Union panel of medicinal experts recommended that the application from Novartis's Sandoz division be approved. A final decision will be made by the European Commission, the EU's executive arm.

Write to Anna Wilde Mathews at anna.mathews@wsj.com and Val Brickates Kennedy at val.kennedy@dowjones.com

URL for this article:
http://online.wsj.com/article/SB118251862394944811.html