Battleground Herceptin: Biocon, Mylan Take Roche Head On With Appeal In Delhi Court
This article was originally published in PharmAsia News
Executive Summary
After being stung by a restraining order related to regulatory approval for biosimilar versions of Herceptin, Biocon and Mylan are appealing a Delhi Court decision that favored Roche.
MUMBAI – Indian biotechnology leader Biocon Ltd. and its biosimilars partner Mylan NV are setting the stage for a grand slugfest against Roche after the Delhi High Court issued an injunction to block Biocon and Mylan from referring to brands like Herceptin, Herclon or Biceltis or to any data relating to trastuzumab.
A source from a Mumbai-based legal outfit told PharmAsia News that the two partners are now filing an appeal to a double bench in the Delhi High Court, and the first hearing could commence soon.
As part of an agreement signed in 2009, Biocon and Mylan teamed up to develop and commercialize, on a co-exclusive basis, several biosimilar brands in India, the first of which is breast cancer treatment trastuzumab branded CANMAb and Hertraz.
"Mylan has challenged an ex parte order in the Honorable Delhi High Court with regard to the proceedings brought by Roche last week aimed at hindering patient access to a more affordable trastuzumab,” Mylan said in a statement. “Mylan is confident that, given the regulatory approval for Hertraz (trastuzumab), the absence of applicable patents protecting trastuzumab in India, and the determination by the DCGI [Drug Controller General of India] that the product is safe and efficacious, Mylan will continue [to] be able to provide access to this very important medicine to those that need it in India.”
Biocon said it could not comment as the case is currently under consideration by the court.
Battle Of The Titans
Roche’s move to block comparisons to Herceptin and other brands caught many by surprise and came at a time when Biocon and Mylan were working on the final contours for the launches of their separate trastuzumab brands. Roche also made the Drug Controller General of India, the drug regulator, a party to the case (Also see "Roche’s Stealth Bomber Blocks Biocon/Mylan From Using Herceptin Name In India" - Scrip, 7 Feb, 2014.).
Justice Manmohan Singh, who had granted restraining orders favoring Roche, had fixed the next hearing for Feb. 28, but with the new appeal filed by Biocon and Mylan, the case will likely be heard much earlier by a new jury.
While Roche has Mukul Rohatgi and Neeraj Kishan Kaul, two of the best known legal experts in India, as its lead counsels, industry sources said Biocon and Mylan have roped in equally big stalwarts to fight for them, but the representatives could not be ascertained immediately. The regulator’s side is likely to be represented by Siddharth Luthra, additional solicitor general of India.
Roche Fights On
In his Feb. 5 ruling, Justice Singh restricted Biocon and Mylan from relying upon or otherwise referring to Herceptin, Herclon or Biceltis or any data relating to trastuzumab marketed as Herceptin, Herclon or Biceltis or claiming any similarity with Herceptin, Herclon or Biceltis. That also includes data relating to the brand’s manufacturing process, safety, efficacy and sales in any press releases, public announcement, promotional or other material for CANMAb and Hertraz.
Justice Singh noted that Roche argued that using terms like “biosimilar trastuzumab,” “trastuzumab” and a “biosimilar version of Herceptin” was misrepresentative because the firms were trying to “pass off” their products to be of the same quality as Herceptin (Also see "Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products" - Scrip, 8 Dec, 2010.).
Roche lawyers said the representations may take unfair advantage of the reputation and goodwill enjoyed by the Herceptin brand as the innovative and original product. Justice Singh in his order agreed Roche would suffer prejudice and irreparable injury if the restraining orders were not passed.
As part of its objections, Roche sought clinical trial data by which the Biocon and Mylan biosimilars were approved by the Drug Controller General of India (Also see "India’s Biocon Wins 1st Biosimilar Approval Of Herceptin; Will Launch Before March 2014" - Scrip, 22 Nov, 2013.). It argued that the Indian biosimilars guidelines were put into effect in 2012, but according to public submissions by Biocon, its Phase III clinical trials were already underway and could not have conformed with the guidelines.
India’s Clinical Trial Registry lists one Phase III trial sponsored by Biocon that compares its biosimilar (Bmab-200) to Herceptin, both in combination with docetaxel, in 132 patients with HER2 metastatic breast cancer.
Defending Biosimilars
According to industry sources, Biocon and Mylan are said to have prepared a strong opposition document against Roche’s charges. Sources say the two partners may contend that although the clinical trials for their trastuzumab had commenced well before the guidelines for biosimilar approvals came into effect in India, no principles were violated that would disqualify their product from regulatory approval.
The “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” stressed comparative safety studies, but they do not make Phase I/II trials for biosimilars a mandatory requirement. Regulatory experts believe Biocon’s clinical trial protocols that were accepted in 2010 conform with the guidelines (Also see "India’s Biosimilars Guidelines Lay Out Best Practices But Marketed Products Not To Be Reviewed – BIO Conference" - Scrip, 19 Jun, 2012.).
Biocon and Mylan are expected to alert the courts that Roche had withdrawn its patents last year and is not entitled to enforce its rights over the product. “Reference to Roche’s global clinical trial data for development of the biosimilar drug or to educate the medical professionals does not imply the right of the innovator is encroached upon,” an expert who works with another Indian company developing biosimilars said.
On the issue of misrepresentation, a source said Mylan and Biocon are likely to stress that their biosimilars are marketed as distinct brands and are not being “passed off” deceptively to resemble Herceptin. “The brands of Biocon and Mylan pronounced as CANMAb and Hertraz are not confusingly similar to Herceptin, Herclon or Biceltis,” the industry source told PharmAsia News.
The Next Leap
At present, the case could go either way and has a good chance of reaching the Supreme Court. Industry experts who spoke to PharmAsia News project three possible scenarios:
- The double or divisional bench may vacate Roche’s restraining orders and side with Mylan and Biocon, which may mean Roche would immediately appeal to the Supreme Court.
- The divisional bench may see merit in the single judge order of the Delhi High Court and side with Roche, which could prompt Mylan and Biocon to appeal to the Supreme Court.
- The divisional bench may find no weight in a separate hearing and refer the case back to the court of Justice Manmohan Singh, who may hear the case on Feb. 28. The final decision, for either side, may still lead to the Supreme Court.