Big hitters bash biogenerics

The threat of generic competition to the top-selling biopharmaceutical drugs has prompted biotechnology's major companies to convene a conference next month to debate this hot topic. Their tactic? To maintain that the manufacturing capabilities of the generics companies do not pass muster.

Companies specialising in the development of biogenerics have started to emerge in the last few years, although to date their activities have been largely confined to regions where intellectual property is not stringently enforced.

Just last week, SICOR 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. 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 patents on biopharmaceuticals start to expire in the US and Europe.

The market is of intense interest to the pharma and biotech industries as the potential global biogeneric sector is estimated to be worth at least $5.0 billion (€4.53bn) in 2004. ABN Amro has said that around $10 billion-worth of biopharmaceutical drugs will be going off patent over the next few years.

The generics industry contends that not only are their manufacturing capabilities as sophisticated and precise as their rivals, but that they have already successfully produced drugs in trials that are the perfect bioequivalents of those they seek to challenge, at much lower cost.

Biotechnology and drug companies have opposed the notion of biogenerics insisting that the molecules or cell lines are too complex to be reproduced in a safe and reliable fashion that guarantees bioequivalency.

One high-profile example that illustrates this concern is the case of epoetin alfa. Amgen developed this drug alongside Johnson & Johnson but last year 141 cases of a serious side effect, red cell aplasia, were linked to a product made at a J&J factory while none occurred in batches made at Amgen's facilities. This led to speculation that differences in the manufacturing process had altered the safety profile of the finished product.

The biogenerics industry maintains that R&D on pharmaceuticals is a public-private partnership, with taxpayer-funded basic and clinical research often complementing the drug industry's efforts. As a reward for their contribution, biopharmaceutical companies should receive a finite period of marketing exclusivity for their drugs, but accept that in time lower-cost generics must become available to improve access and reduce health care expenditures.

The conference, organised by Strategic Research Institute​ and scheduled to take place in Reston, Virginia, US, on 22-23 October, will be attended by the main biotechnology and pharmaceutical companies, generic biopharmaceutical specialists and regulators from the US, Europe and Canada.