A lineup of blockbuster monoclonal antibodies produced by a group of the world's top biopharma companies are now squarely in the crosshairs of the world's top biosimilar developers.
Last Friday the European Medicines Agency laid out exactly what developers will need to do to gain approvals for follow-on antibody therapies. And Roche, with its lineup of aging cancer therapies like Rituxan, Herceptin and Avastin, was quickly singled out as the most vulnerable to a new lineup of competitive treatments that could hit the European market as early as 2012. The Financial Times also notes that Merck KGaA, Johnson & Johnson ($JNJ) and Abbott ($ABT) also face near-term competition from the biosimilar crowd. GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) are likely to face new competition at a later stage.
Several big outfits like Novartis ($NVS), Teva and Hospira ($HSP) are likely to lead the charge in creating biosimilar versions of the blockbuster antibodies. But it won't be cheap. The research group Collins Stewart has estimated that developers will need to budget $100 million for the kinds of clinical trials that will be required to gain an approval. And once they hit the market, the follow-ons are expected to offer discounts of 10 to 15 percent.
Roche wants regulators to be cautious and slow. "We believe that patient safety must be of highest concern when evaluating the development, approval and marketing of biosimilar products." In the U.S., the FDA is just beginning the process of laying out the rules for developing biosimilars.
EU adopts new biosimilar guideline :
European regulators have adopted a guideline on biosimilar antibody drugs; industry can expect its publication in a couple of weeks. However, many experts already anticipate a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody, as Reuters notes.
In a release, the EMA briefly touched on the guidelines, titled 'Similar Biological Medicinal Products Containing Monoclonal Antibodies,' which will be released for a five-month public consultation period. "This guideline lays down the nonclinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed," it explains.
Earlier this week, Lincoln Tsang, a partner at London law firm Arnold & Porter, told Reuters he expects the EMA to play it safe by requiring extensive testing. "My hunch is that they will be cautious in saying that if you can establish clinical efficacy and safety of a given product for a given indication you can't readily seek approval for another indication," he said. "Given it is such a big therapeutic area, I think they will not like to be seen to be too generous."
As Reuters notes, such testing could drive up the costs of producing biosimilars, thus making it hard for smaller companies to enter the arena. If costs are too high, only well-established players like Teva, Novartis and Hospira might have the ability to bring such products to market.