FDA approvals for biotechs decline

The US FDA approvals for biopharma products plunged in 2007.

Is the biotechnology running out of steam after many years of great growth in terms of new product development? This is the question on every analyst's mind after a just released study on the approvals of biopharmaceuticals in the last decade, done by Dr Ronald A Rader. For an industry used to getting approvals for close to two-dozen products every year, the year 2007 was dismal with the US government's Federal Drug Authority (FDA) approving only 11 biopharmaceutial products for marketing in the last 12 months.

It followed a dismal 2006 when only 10 biopharma products got the FDA approval. Biopharmaceuticals represent a class of pharma products that include recombinant proteins, monoclonal antibodies (mAbs) and some indications of existing drugs to treat various types of cancers.

A comprehensive study on biopharmaceutical products in the US and European markets, analyzing the regulatory trends between 1995 and 2007 by Dr Rader, has appeared in the March 15, 2008 issue of Genetic Engineering and Biotechnology News (GEN).

Some analysts have blamed the cautious approach adopted by FDA in the wake of recent controversies leading to the withdrawal of several pharmaceutical products from the market after the discovery of unintended side-effects and even dozens of deaths.

However, Dr Rader notes that relatively few filings for biopharmaceuticals have been arbitrarily delayed, put on long-term hold or denied. Rather, it appears that fewer products are successfully making it through pivotal phase III trials.

Dr Rader reasons that FDA may well be slowing down and shifting its approval criteria to be more restrictive, but most of the biopharmaceuticals affected by FDA delays or denials had problems, usually not attaining their preset primary endpoints in pivotal trials or otherwise having problems with safety or efficacy.

The industry will be watching with bated breath the fate of nearly two dozen filings for regulatory approvals from the industry which are currently pending with the FDA. An equal number of filings are expected in 2008 too.

Dr Rader's study showed that the FDA approved an average of 16.6 products in the years between 1996 and 2005. The year 1997 was the best ever period for the biotech industry with FDA approvals for a record 23 products, which included 12 recombinant proteins and mAbs.

Most of the 11 approvals in 2007 were incremental advances, me-too products, and those with rather specialized indications. Besides a low level of novelty (with many products and their indications similar to those of prior products), none of the 2007 products are expected to significantly improve healthcare for large numbers of patients, emphasized Dr Rader.

The 2007 approval with by far the most potential impact, Mircera (pegylated recombinant erythropoietin--PEG-EPO), from Roche, will probably not be sold in the US for at least several years due to patent infringement issues. Without Mircera, a likely blockbuster, the projected market for all products approved in 2007 does not even attain blockbuster level (>$1 billion per year revenue). The low number of recombinant protein or mAb approvals in 2007 (only two) is more typical of the 1980s. And other than a formal approval for Epicel (cell cultured skin patches) from Genzyme, a product already marketed for 20 years, no established or mainstream US biotechnology company received an approval, with approvals primarily granted to large foreign and small, new entrant, US biotech companies.

Hardly any mAbs or cancer therapeutics was approved in recent years, despite seemingly endless hype about large numbers in development. No biopharmaceuticals were approved for cancer indications in 2007, only one was approved in 2006, and only one mAb received approval in both 2006 and 2007.