FDA 'must move faster on biogenerics'

Related tags Human growth hormone Pharmacology Growth hormone Food and drug administration

The Generic Pharmaceutical Association (GPhA) has urged the US Food
and Drug Administration (FDA) to move forward to accelerate the
approval of affordable generic versions of biopharmaceutical drugs.

The GPhA's comments come in the wake of a public meeting to discuss the formulation of a regulatory route to market for so-called biogeneric or biosimilar products.

"Sound science supports our position,"​ said GPhA president and CEO Kathleen Jaeger. "A scientific basis clearly exists to permit the FDA approval for a vast array of generic biopharmaceuticals. As to other more complex biopharmaceuticals, it is only a matter of time before the science is solidified to support approval of generic versions of these products."

Companies specialising in the contract manufacture of conventional and biological active pharmaceutical ingredients (APIs) are watching the progress of the deliberations in the US - the world's biggest market for drugs - with keen interest.

Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s - including human growth hormone (hGH) and insulin - are set to lose patent protection in the US in 2005 and beyond. This opens up a market currently worth $30 billion (€)and growing at 10 per cent a year - but only if a regulatory route to market can be teased out.

API and generic companies are hoping that biologicals can provide additional impetus to the strong growth being seen in the market for chemical-based generics worldwide. Biogenerics could quickly address a $10 billion market in which many treatments cost upwards of $10,000 per patient per year, according to Jaeger.

"The generic pharmaceutical industry can provide consumers with safe, effective and affordable biopharmaceuticals,"​ said Jaeger. But she accused Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organisation - which represent the interests of the research-based pharmaceutical and biotech sectors - of 'dragging their feet into the world of competition by undertaking efforts to block consumers' timely access to affordable biopharmaceuticals'.

"These delay tactics are harming the millions of Americans who need access to affordable health care,"​ Jaeger said.

In response, the companies that research biological drugs point out that the complexity of their production means that it is hard to guarantee equivalency - the benchmark for approval of generic drugs - for both efficacy and safety. This is backed up, for example, by the serious side effects that emerged with one of the erythropoietin drugs, which eventually was attributed to changes in its production schedule.

This has placed regulators in a quandary, amply evidenced by the FDA's inability to reach a decision earlier this month on the marketing application by Sandoz of a generic human growth hormone product, Omnitrope.

The FDA said at the time that it did not identify any deficiencies in the application, but 'uncertainty regarding scientific and legal issues' meant it had been unable to reach a final decision.

"Given escalating pharmaceutical expenditures and the broader healthcare crisis, the time is now for the FDA and Congress to commence competition for expensive biopharmaceutical medicines so that consumers can have timely access to these lifesaving products,"​ Jaeger continued.

She added that biogenerics not only will provide patients the same health benefits as their brand counterparts, but also yield tremendous cost savings for consumers and healthcare providers by creating healthy competition. Competition also will foster innovation in the biopharmaceutical industry, she said.

And while the US is debating the manufacture of generic biopharmaceuticals, citizens of other nations are already enjoying access to more affordable generic biopharmaceutical products, according to Jaeger.

With approximately 350 products in clinical testing and more than 1,000 others in early development phases, biopharmaceuticals are growing at almost twice the rate of total pharmaceuticals.

But to date approval of biogenerics has been patchy to say the least. Last year, SICOR (now part of Teva) gained approval in Lithuania for a generic version of granulocyte colony stimulating factor (G-CSF), the active principle in Genentech's Neupogen (filgrastim) drug for treating neutropenia in patients undergoing cytotoxic cancer chemotherapy.

Meanwhile, other companies, for example Wockhardt (with erythropoietin) and GeneMedix (with granulocyte macrophage colony stimulating factor or GM-CSF), have concentrated on Asian markets until such time as a route to market for these drugs in the US and Europe opens up.

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