FDA Matters Blog

Archive for the ‘Follow-on Biologics’ Category

FDA: An Honest Broker on the Slow Path to Biosimilars

Sunday, October 24th, 2010

FDA Matters‘ enthusiasm for biosimilars is a matter of public record. The market will build slowly, but 10 years from now the new law will be seen as ushering in a new age of biopharmaceutical product development. FDA will present the next glimpse of the future on November 2 and 3, 2010, when it holds hearings on implementing the new approval pathway.

The key to the future will be the FDA’s strong commitment to expanding prescriber and patient choice among biological products. FDA will be satisfied (and successful) if the new law stimulates biosimilars, bio-betters, and innovative new biological products, along with a dramatic increase in knowledge about the nature and characterization of biologic products. (more…)

Hot Town, Summer in the City—2010

Sunday, July 11th, 2010

For the news media, the only FDA story this coming week will be the two-day advisory committee meeting reviewing the diabetes drug, Avandia. Based on an earlier article (link below), FDA Matters will be looking at how Dr. Hamburg’s FDA handles the discordant voices coming from within the agency.

Missing from public dialogue is the extraordinary (perhaps unprecedented) number of large, consequential projects that FDA will be working on this summer. Every part of FDA is involved in some initiative that could become a “game-changer” for the agency. (more…)

Orphan Drugs and Bio-Similars: Is 12 Better than 7?

Sunday, May 16th, 2010

In the new bio-similars legislation, orphan drugs were granted protection for the longer of 12 years of data exclusivity or 7 years of market exclusivity. Since both are triggered by the date of approval, many people have assumed that 12 years protection is always better than 7 years protection.

FDA Matters says: not so. Other than patent protection, the Orphan Drug Act’s grant of market exclusivity to orphan drugs is still the best friend of an innovator company. (more…)

Data Exclusivity and Bio-Similars: Both More and Less Than It Seems

Sunday, May 2nd, 2010

FDA Matters has been very upbeat about the prospects for the bio-similar marketplace. “Smart money” (i.e. companies currently making billions from their ability to discover or license new bio-pharmaceuticals and market them) decided to play before they knew the ground rules on exclusivity and patents. We can only conclude that there must be substantial amounts of money to be made, regardless of the specifics.

With this in mind, FDA Matters explores why there is a persistent belief that the bio-pharmaceutical industry got something better than data exclusivity. I also explore whether data exclusivity will really provide valuable protection for original reference biologic products. (more…)

It’s 12 Years of Data Exclusivity

Wednesday, March 31st, 2010

For an updated analysis, go to the May 2, 2010 column: Data Exclusivity and Bio-Similars: Both More and Less Than It Seems.Read the rest of this entry »

On several occasions, FDA Matters has asked Congressional staffers: how many of the Senators and Representatives understand that the follow-on biologics debate is about the amount of data exclusivity, not market exclusivity? In reply, I always get a smile that confirms my suspicion.

The confusion is not limited to the Hill. The New York Times referred to “market exclusivity” in its article on industry winners and losers on the day of the key House vote. A prominent industry trade publication—whose staff clearly knows better—referred to “bullet-proof market exclusivity” in a story the next day. The San Francisco Chronicle got it right—perhaps because of the concentration of bio-pharmaceutical companies in the Bay Area.

None of this would matter if data and marketing exclusivity were similar to each other…or even of roughly equal value. They are not. The future of bio-similar products cannot be understood without grasping the difference. (more…)

Mr. Brown Goes to Washington

Sunday, January 24th, 2010

The election of Massachusetts’ new Senator, Scott Brown, has set off a media frenzy about the fate of health care reform legislation. However, the ramifications of his election reach far beyond health reform.

FDA turns out to be a good example. FDA Matters sees at least three consequences of his election that may affect the agency in 2010. (more…)

Messages to the FDA-Regulated: Seven Columns to Re-read for 2010

Sunday, January 3rd, 2010

This past year has been a tumultuous one for FDA-regulated industries as they struggled to provide new and safer medical products and safer foods, while weathering much criticism.

FDA Matters has explored a number of industry issues in 2009. As they evolve in the new year, I will continue to provide readers with my analysis and commentary. Meantime, here are seven columns that provide insight about FDA-regulated companies. They provide useful background for 2010: (more…)

House Votes on Health Reform: What’s Next?

Sunday, November 8th, 2009

By the incredibly close margin of 220 to 215, the US House of Representatives adopted health reform legislation on Saturday evening, November 7, 2009. In the end, abortion restrictions were added…and liberals were forced to accept these and provide the margin of victory.

The content of the House bill is of little significance. However, its passage is an historic event, creating a near-certainty that President Obama will be signing final legislation in the next 3 months. (more…)

Health Reform and FOB’s: From Debate to Done in Thirty Days

Sunday, October 11th, 2009

On Tuesday morning, October 13, the Senate Finance Committee is scheduled to vote on its version of health reform legislation. This is ground zero in a contest of political will and national priorities that began over 65 years ago. This is big…a tidal wave of change coming to the US health care system.

The Finance Committee bill, once passed, will be melded with the version passed in the Senate Health, Education, Labor and Pension (HELP) Committee. Although it’s a small detail in the massive health reform bill, the future of follow-on biologics (FOB’s) depends on what comes next. (more…)

Fall Scorecard for Follow-on Biologics

Friday, September 11th, 2009

The creation of a regulatory pathway for follow-on biologics (FOB) has become a favorite topic of FDA Matters. The substance of the legislation is important and the politics are fascinating. It should get even better this fall. (more…)

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