Sri Lankan court dismisses Roche's lawsuit to ban distribution of biosimilars produced by Biocad

After a series of hearings, the Court of Appeals of Sri Lanka has finally dismissed the claims from Swiss pharma giant Roche (ROG: SIX) in a lawsuit seeking to stop distribution of the Russian-made anti-tumor biosimilar products, as well as seeking to revoke Biocad’s product market authorization in Sri Lanka for the anti-cancer drugs trastuzumab and bevacizumab.

In late March this year, Roche filed a lawsuit against a local distributor of Biocad in Sri Lanka, asking to ban the distribution of trastuzumab (band name Herceptin) and bevacizumab (brand name Avastin) manufactured in the Russian Federation by a leading Russian biotechnology company, JCS Biocad. The plaintiff claimed that substantial violations of the drug manufacturing process had been committed by the agency during the approval. In particular, products by Biocad lacked proper clinical trials, and therefore no market authorization could have been issued for two Biocad’s products in Sri Lanka.

During a series of hearings in March 2016, Biocad provided assistance to the local partner, offering proof that the plaintiffs’ claims were totally unfounded. The Court decided with the local distributor of Biocad’s products and dismissed Roche’s lawsuit, lifting its “stay order” on distribution and sales of two biosimilar drug products manufactured by Biocad in Sri Lanka.