Roche doesn’t see a threat from biosimilars till 2015

September 6, 2012 6:35 AM

Roche, the Swiss Pharma giant, believes the threat from biosimilar copies of its cancer drugs has been pushed back as companies developing the cut-price biotech medicines face development hurdles.

David Loew, the firm’s marketing head, said on Wednesday that he did not now expect any biosimilar versions of Roche’s blockbuster antibody drug Rituxan (Mabthera except US), one of the first to face such competition, before the first quarter of 2015.

That is later than many analysts have forecast, since the drug loses patent protection in Europe at the end of 2013 and biosimilar copies are already being developed by several generic drugmakers, including Teva, Sandoz and Celltrion.

Loew told analysts at a meeting in London that one reason for the delay could be that biosimilar companies were having to add more patients to clinical studies to satisfy European regulators about the safety and efficacy of their products.

Rituxan, which was Roche’s top-selling medicine last year with sales of 6.01 billion Swiss francs ($6.29 billion), is used to treat cancer of the lymphatic system, as well as rheumatoid arthritis.

Several companies are racing to produce biosimilar copies of injectable biotechnology drugs like Rituxan, in a drive that threatens to undermine the sales of original products made by Roche and other biotech firms.

The process, however, is far from straightforward, since tiny differences in manufacturing mean biological drugs are impossible to replicate exactly. As a result, clinical trials are needed before approval, making biosimilar much more costly to develop than copies of standard “white pill” medicines.

 

Source: Chicago Tribune

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!