Mylan’s Rollout Of Herceptin Biosimilar In India To Begin Its March Into Emerging Markets

Experience gathered from the launch of trastuzumab copies in India will help position Mylan in several other emerging markets, execs tell PharmAsia News. Meanwhile, the global generics giant also inks a deal to become the exclusive partner for Gilead’s branded medicines business in India.

MUMBAI – Global generics giant Mylan NV is the latest to join a growing list of players in the biosimilars business, as it announced Feb. 4 the India launch of its trastuzumab brand Hertraz. The product, which will be available in 150 mg and 440 mg dosages, is the first in a handful of monoclonal antibodies Mylan is co-developing with Indian biotech Biocon Ltd. under a 2009 deal.

Mylan hopes a significant number of Indian HER2-positive breast cancer patients will access its drug at a 25% price discount from Roche’s Herceptin, sold in India as Herclon or as Biceltis by Roche partner Emcure Pharmaceuticals Ltd.

Ready, Steady, Go

The competition between Biocon and Mylan on one side pitted against Roche and Emcure on the other will be closely watched on the expectation that both sides will try to offer the drug through various schemes to make it more affordable.

Although Roche cut the price of its trastuzumab brands in the last two years in India, Mylan and Biocon are playing up the affordability plank, noting the expected launch of the biosimilar triggered the price discount offered by Roche (Also see "India’s Biocon Wins 1st Biosimilar Approval Of Herceptin; Will Launch Before March 2014" - Scrip, 22 Nov, 2013.).

Roche’s Herclon and licensed Biceltis are listed at a price of INR 75,000 ($1,199) for a 440 mg dose, but can come down to INR 55,000 through discounts given via the trade channel, according to sources. Mylan’s Hertraz and Biocon’s brand Canmab are listed at INR 56,500 for 400 mg and INR 19,500 for 150 mg. Hertraz and Canmab 400 mg list prices are on par with Roche’s discounted prices, but the biosimilars are expected to be discounted as they go through sales channels.

Mylan said its pricing strategy is aligned with Biocon and that higher volume uptake in India could lead to further cuts in price. Mylan is also making plans to boost awareness of breast cancer and facilitate early detection in India.

A critical differentiator could be the 150 mg dose offered by Biocon and Mylan. The companies say the smaller dose could play a decisive role in gaining market share from patients who prefer to spread expenses over the month rather than paying a lump sum for the 440 mg dose sold by Roche and Emcure.

For its part, Roche has argued that drug access is not solely about price but also depends on health care infrastructure, including hospitals, diagnostics and health care professionals, which are critical to cancer medicines such as Herceptin. Roche has also said it would like to take a closer look at the data behind the Indian approval of Canmab and Hertraz (Also see "Biocon’s Lower-priced Herceptin Biosimilar Ready To Roll But Roche Has Questions" - Scrip, 20 Jan, 2014.).

Indian regulators approved the biosimilars based on local clinical trials conducted by Biocon, including a 132-patient Phase III trial. Mylan is also conducting a 600-patient Phase III trial in Europe that will be used for global submissions.

Herceptin is Roche’s third best-selling drug, booking global sales of $6.7 billion in 2013, although sales in India were only $21 million in 2012, according to Mylan.

Learning From India

Speaking to PharmAsia News, Mylan President Rajiv Malik, who is responsible for global operations, indicated that the India launch of Hertraz will mark the first phase of a rollout of Hertraz in emerging markets like Sri Lanka and parts of Africa where Indian clinical trial data are accepted. Malik noted the launch of Mylan’s maiden biosimilar is the beginning of a journey to provide affordable treatment to HER2 breast cancer patients.

Rakesh Bamzai, who joined Mylan in January as president of India and emerging markets after 18 years with Biocon, said epidemiology suggests strong demand for the drug.

According to Bamzai, India is home to 140,000 breast cancer patients, of which 30% are believed to be HER2 positive. Of India’s roughly 40,000 HER2 breast cancer patients, Bamzai says only 8,000 can currently afford the drug, which leaves at least 32,000 patients Mylan can target for treatment.

Asked about Mylan’s global plans to launch Hertraz, Malik said the company is mapping the world market, as it holds exclusive rights to the drug in the U.S., Canada, Australia and Europe and has a co-exclusive commercialization deal with Biocon for several emerging markets.

EU Launch By 2017-2018

Malik predicted a European launch for Mylan’s trastuzumab by 2017-2018, but no earlier. “That is because of the time taken for clinical trials, which will take us time by the end of this year or the next year and then the regulatory process will start. We are planning the launch of our biosimilars after that process,” he said.

Herceptin loses patent protection in the U.K. in July 2014, but the product retains patents until August 2015 for most European countries and until 2019 in the U.S.

Roche has been planning for biosimilar competition by developing new drugs that it hopes will change the standard of care. In Europe, for instance, Roche has approval for an injectable version of Herceptin, and the company is also moving patients to Perjeta (pertuzumab) used in combination with trastuzumab and docetaxel. The Swiss pharma also has launched a Herceptin-containing antibody drug conjugate Kadcyla (ado-trastuzumab emtansine).

Emerging Market Plan Includes Gilead

Malik noted that emerging markets are ripe for biosimilars but emphasized that each has distinct attributes. In India, Malik said, the market has gone through a turbulent phase with new pricing and investment policies; the Indian government said in November it will “for the moment” not impose new restrictions on foreign investments in existing Indian drug firms (Also see "Global Firms Can Now Buy A Controlling Stake In Indian Companies, But The Debate Is Not Over" - Scrip, 2 Dec, 2013.).

In India, Mylan is set to enter two new therapy areas – critical care and gastrointestinal, according to Malik. The critical care segment will be helped by Mylan’s recent acquisition of Agila Specialties Pvt. Ltd., while Mylan has its own pipeline of gastrointestinal therapies.

Malik said the company is slowly being recognized in India and predicted a meaningful size could be achieved either organically or through buyouts. The company will buy when a genuine need is felt. “We have taken some time to ramp up in India, but our focus is not off the market,” he said.

As a case in point, last week Mylan became the exclusive commercial partner in India for Gilead Sciences Inc.’s branded medicine business, including HIV drugs Viread (tenofovir), Truvada (emtricitabine/tenofovir) and Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir). The agreement also includes the antifungal AmBisome (amphotericin) and Viread for chronic hepatitis B.

In addition to distributing Gilead’s branded medicines, Mylan will also manage regulatory and pharmacovigilance activity for Gilead in India along with broader medical education initiatives. Terms of the deal were not disclosed. The U.S. companies have been partners since 2006, when Gilead granted Mylan rights to manufacture and sell generic versions of Gilead HIV therapies in India and 111 developing world countries.

Like with Gilead, Malik said Mylan is seeking global partners that have innovative drugs but lack commercial scale in India. Mylan’s present strength of 500-plus medical representatives in India is likely to increase as Malik noted the company is still in its investment phase.

Mylan is also firming up its China strategy, Malik said. Those plans contrast with the recent move by generics rival Actavis, which said it would pull out of China (Also see "Actavis Follows Up On Pull-Out Threat, Sells China Unit To Zhejiang Chiral" - Scrip, 27 Jan, 2014.).

[Editor’s note: This story was contributed by PharmAsia News , which provides daily coverage of the Asia biopharmaceutical industry and regulatory policies. To learn more, sign up for a free trial – no credit card needed.]