Roche Fears 'Real' Biosimilar Competition Says Russia's Biocad
Executive Summary
Russia's Biocad has lashed out against Roche after being at the receiving end of what it claims are the Swiss multinational's 'scare tactics' against biosimilar competition in Sri Lanka. Biocad says it intends to pursue damages in the Sri Lankan case while Roche, which is standing its ground, has moved the Supreme Court in the island nation.
A Court of Appeals of Sri Lanka had recently dismissed Roche's claims questioning the marketing authorization of Biocad's trastuzumab and bevacizumab in the country. In March, F. Hoffmann-La Roche Ltd. filed a suit against a local distributor of Biocad in Sri Lanka, seeking a ban on the distribution of the products. Roche is said to have claimed, among other things, that Biocad's products lacked proper clinical trials.
In response, Biocad has decried Roche's actions stating that the Swiss firm's claims were "a scare tactic detached from reality".
It told Scrip that the "roots" of Roche's "scare and bullying" tactic lay in the Swiss multinational's fear of facing "real competitors" who have high-quality drugs at affordable prices.
Roche, which has "penetrated markets for so long as a monopoly", now finds it challenging to face real competitors with comparable products, Biocad claimed.
The Russian firm believes that Roche will act "using the same path" in all emerging markets worldwide. Roche is engaged in similar high-octane litigation in markets like India. (Also see "Indian Herceptin Biosimilars Case Simmers" - Scrip, 29 Apr, 2016.)
Biocad told Scrip that both its trastuzumab and bevacizumab were studied in Phase III international multi-center trials versus "original" Roche products and based on these study results the products received market authorization in Russia, Belarus and other countries.
"More than 100 patients from Russia, India, Ukraine and Belarus were included in each protocol. Clinical studies design (patient population, endpoints, etc.) is aligned with modern European requirements for biosimilars," Biocad explained.
The Russian firm underscored that it did not infringe any patents related to these products either in Russia or Sri Lanka.
Frivolous Lawsuit
Biocad said that Roche’s lawsuit endangered the life and well-being of patients in need of affordable cancer treatment in Sri Lanka and made them wait for the life-savings medication for several months. Biocad's biosimilar versions are significantly less expensive than the originator products in Sri Lanka.
It also claimed that Roche's court proceedings were aimed at putting a "temporary ban" on distribution of the two Russian drugs primarily to prevent the distributors of the products from participation in competitive bidding initiated by Sri Lankan hospitals for oncology biological drugs purchases.
Biocad, though not a direct respondent in the suit in Sri Lanka, added that it was in the process of developing the "most effective" strategy for making Roche liable for damages caused to Biocad and patients in Sri Lanka by its "frivolous" claims.
"The claim is under drafting, but has not been filed yet," Biocad told Scrip.
Biocad was also earlier reported to have filed an anti-trust suit against Roche in the US District Court for the Southern District of New York. Biocad has accused Roche of pumping up prices of its anticancers Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab) in the US while destroying competition with predatory pricing of the products in Russia so as to hold off any US entry of biosimilars.
Roche's View
Roche, in the meantime, is standing firm in Sri Lanka. It has appealed the recent ruling in the case and says that a Supreme Court hearing on its appeal has been scheduled.
The Swiss multinational told Scrip that it had a "responsibility" to ensure that if a product claims to be a biosimilar of, or similar to, one of its biotherapeutic products, that such a claim is "scientifically justified".
"Herceptin (trastuzumab) is used for the treatment of a particularly aggressive form of breast cancer. Today when a physician prescribes or a patient agrees to treatment with trastuzumab, they do so based on their understanding of our product’s established efficacy and safety profile, "Roche said.
Roche also said that while at least one product "claiming to be trastuzumab" had recently been approved under the INN trastuzumab in Sri Lanka, there was "very limited information" on the product in the public domain.
"There is no public data available whether it has met local and WHO defined requirements for establishing biosimilarity. We consider it our duty to raise these questions because we believe it is essential to ensure that physicians can make informed decisions," Roche said.
It also maintained that in taking legal action, it was seeking to understand how the product was approved in Sri Lanka and what evidence had been generated to support its use for the treatment of HER2 positive breast cancer.
"There is no room for uncertainty when it comes to treatments for cancer so we hope our answers will soon be addressed."
Roche has expressed similar concerns over regulatory approvals for biosimilar versions of Avastin in India. (Also see "Indian Avastin Biosimilar Arrives Amid Roche's Charges" - Scrip, 10 Jun, 2016.)