Due to unsubstantiated, frivolous claims by Swiss drug-maker F. Hoffmann-La Roche, Ltd. in a desperate attempt to cease the distribution of the Russian-made anti-tumour biosimilar products, as well as seeking to revoke BIOCAD’s product market authorization in Sri Lanka, cancer patients in this South-East country haven’t received the essential anti-cancer drugs trastuzumab and bevacizumab in time.
After a series of hearings, in late June the Court of Appeals of Sri Lanka finally dismissed the claims from the Swiss originator and terminated interim in relief
In late March this year F. Hoffmann-La Roche Ltd. filed a lawsuit against a local distributor of BIOCAD in Sri Lanka, asking to ban the distribution of trastuzumab and bevacizumab manufactured in the Russian Federation by a leading Russian biotechnology company, JCS BIOCAD. The Plaintiff claimed that substantial violations of due of 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.
According to a BIOCAD press release, during a series of hearings that followed, the company provided essential assistance to the local partner, which gave proof that the Plaintiffs’ claims were a scare tactic detached from reality. The Court decided with the local distributor of BIOCAD’s products and dismissed F. Hoffmann-La Roche’s lawsuit, lifting its “stay order” on distribution and sales of two biosimilar drug products manufactured by BIOCAD in Sri Lanka.
“We consider the incident as an attempt of unfair competition, detrimental to the health of patients. The Sri Lanka’s Court of Appeal has arrived at essentially the same conclusion. We intend to call Hoffmann-La Roche to answer for its unfair practices”, said Dmitry Morozov, BIOCAD’s founder and CEO, commenting on the results of the court’s decision.
F. Hoffmann-La Roche Ltd. today controls the lion’s share of pharmaceutical market in Sri Lanka, and initiation of the court proceedings aiming to put temporary ban on distribution of two Russian drugs has only one goal - to prevent distributors of the Russian-made advanced biotech drug products from participation in competitive bidding initiated by the hospitals of Sri Lanka for oncology biological drugs purchases in accordance with the national needs.
Trastuzumab and bevacizumab produced by JSC BIOCAD are successfully used in several countries around the globe for cancer treatment, showing the effectiveness that falls well within the EMA’s recommendations for biosimilarity when compared to the original drugs from F. Hoffmann-La Roche. In multi-national clinical trials they were compared to the originator products before their use was approved. In Sri Lanka, however, they are 2,5 times less expensive than the originator products. Hoffmann-La Roche’s frivolous lawsuit endangered the life and well-being of patients in need of affordable cancer treatment in Sri Lanka and made patients wait for the life-savings medication for several months.
The recent court case clearly demonstrates that the best Russian biotechnology companies are expanding their business activities rapidly in foreign markets by offering the high-quality products at much lower prices. This causing grave concern to Hoffmann-La Roche and, possibly, other originators who may be ready to engage in unfair competition practices even if this means putting the health of their patients at risk.
BIOCAD considers these practices unacceptable. In this particular case, JSC BIOCAD, although technically was not a respondent in the lawsuit by F. Hoffmann-La Roche Ltd. in Sri Lanka, has intentions of filing a lawsuit to oblige F. Hoffmann-La Roche Ltd to compensate the damage caused to JSC BIOCAD as well as provide evaluation and compensation of damage caused to the health of Sri Lanka patients resulting from legal misconduct on the part of Swiss drug manufacturer.