At approximately 40 per cent of the cost of the innovator, Emcure Pharma’s Eribilin is definitely a more cost effective alternate to Eisai Pharma’s Halaven but clinicial outcomes will depend on the quality of the generic drug By Usha Sharma
The cancer market in India is a very niche segment as compared to the pharmaceutical market consisting of acute and other chronic therapies. Almost all pharma companies, including domestic and multinational entities, operating in the market are striving to expand their portfolio. According to information available in the public domain, India’s onco drug market comprises 140 molecules with 1337 brands. Most MNCs are present in the market with their originator products, whereas domestic pharma companies with generic versions. The latter are generally more affordable than the former and in the case of small molecule drugs. Crucially, both versions have the same chemical composition delivering the same health outcomes.
Growing incidence of cancers
Four top cancer research groups, namely; American Cancer Society (ACS), Cancer Prevention and Control (CDC), National Cancer Institute (NCI) and North American Association of Central Cancer Registries (NAACCR) have recently released their 2018 Annual Report in the US. The report provides an update on the Status of Cancer disease, which highlights overall, cancer death in the US. The report mentions that cancer death rates for women have declined an average of 1.4 per cent per year over the most recently studied five years while incidence rates have remained stable.
As per the information available in the public domain, breast cancer is the most common cancer in women and 271,270 new cases are expected in the United States in 2019. The next most common cancers are lung cancer and prostate cancer. In India, as well, breast cancer remains the most common cancer in women. With an age-adjusted rate of 25.8 cases per 100,000 women and a mortality rate of 12.7 per 100,000 women. Incidence of metastatic breast cancer (MBC) has been reported to be approximately five per cent to 25 per cent from various centers in India.
Various Indian studies suggest that about 20 per cent of breast cancers are triple-negative breast cancers. Triple-negative breast cancer (TNBC) is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. It means that the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. Even though chemotherapy may work well for this type of breast cancer, the chance of relapse is high and the overall prognosis is poorer than the other types of breast cancer.
Do we have solutions?
To make cancer drugs accessible and affordable the Government of India cracked down on prices of onco drugs in the past one year. The latest anouncement on the capping of trade margins of 42 cancer drugs is one example of this stance. Cancer therapy could also get more affordable as key onco drugs go off patent in the next few years. For example, Roche’s Avastin (bevacizumab) who’s patent expires in 2020. Roche’s Herceptin (trastuzumab) also goes off patent in 2019 in the US. Another important patent expiry being tracked is that of Eisai Pharmaceutical’s Halaven’s (eribulin) with the first of five patents in the US expiring on June 16 this year.
One of the first generic versions of eribulin for the treatment of metastatic breast cancer (MBC) was recently launched by India’s Emcure Pharmaceuticals in March. Commenting on the launch Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals said, “Under the guidance of Dr Mukund Gurjar (CSO), the company worked on this molecule for about a year focusing on both API and formulation development. The chemical structure of this API is one of the most complex molecules ever commercialised. A group of highly-trained Ph D level scientists were able to accomplish this challenging task in a very short period of time.”
Explaining the quality process and regulatory compliance in Eribilin, he informed that, “Chemically both (Eisai’s Halaven and Emcure’s Eribilin) molecules are same. Eribilin is not different from Eisai’s Halaven. It’s the first generic version, which will have a same dosing regimen as of Halaven.”
When we contacted the innovator of Halaven, Eisai Pharma, to comment on the quality and impact of drug in the Indian market, Dr Sanjit Singh Lamba, Managing Director, Eisai Pharma said, “We acknowledge the launch of Emcure’s Eribulin; however, we cannot comment on its impact at this moment as we don’t know their product.” In India, Halaven is the recognised chemotherapy brand in MBC in its fifth year of launch. And it is approved for subtypes steroid sulfatase (STS).
In India about 20 per cent of breast cancer patients have triple negative breast cancer. In terms of values, this niche segment is approximately Rs 50-60 crore. With this launch, Emcure will have access to a considerable business market. Commenting on the Indian metastatic breast cancer market and business potential, Iyer said, “We at Emcure are targeting to catch 25 per cent of this market. At the same time, we are planning to expand the market by offering the drug at a much cheaper price for the benefit of patients.”
The high treatment cost made it difficult for many patients to opt for it. Hence, the innovator of Halaven introduced a tiered pricing programme. Informing more about the programme, Lamba said, “As the originator of Halaven and the first to launch a tiered pricing programme in this area, we aim to further contribute to increasing the quality of life of patients with MBC in India.”
Will Emcure be considering the same feature to increase accessibility?
Iyer comments, “We are offering the drug at a price 40 per cent lower than the innovator, thereby increasing the patient pool, who will now be able to afford this drug.” The cost plays an important role and generic players too. During the launch of Eribulin, Iyer informs, “Incidence of breast cancer is on the rise in India and being a price sensitive market with low awareness, we aim to provide a proven and cost-effective treatment of high quality and efficacy as offered by the innovator brand and it is a cost-effective option for patients,”
Adhering to quality
Eribulin is an injectable medicine and needs to be administered by a qualified physician consultant. Dr Adwaita A Gore, Consultant Medical and Paediatric Oncologist, Hemato Oncologist & Bone Marrow Transplant Physician, Prince Aly Khan Hospital and Zen Multi Specialty Hospital says, “Eribilin (Emcure) is the first Indian generic developer after the innovator Halaven (Eisai Pharma). History has shown evidence that the availability of generic drugs at an affordable cost makes the drug available for larger group of patients by providing an option.”
The toxicity profile of the drug is as low as compared to other drugs and is well tolerated. Infusion time is 2-5 min which is short and would not require longer hospital stay. Since the drug is administered intravenously, physicians can closely monitor and the actual requirement of the drug can be managed. Stressing on how eribilin will comply patient adherence Iyer informs, “IV drugs can be monitored closely and thereby the compliance is high. The physicians also need not worry about a patient missing a dose or taking an extra dose like in the case of oral drugs.
Commenting on the adherence aspect, Gore said, “It helps in expanding the market and opens a different option for therapy. The drug schedule is very comfortable for patients as it can be administered in a day care setting and does not require long hospital stay. The adherence depends on multiple factors and drug cost and convenient dosing are just two of many parameters in consideration.”
While judging the drug quality and confidence about it, Gore expressed, “ We all know that generic drug product is approved by regulatory authorities (eg. in India – DCGI, USA – FDA) when it has met their standards with respect to quality, purity, potency, strength and identity. Cost is the main difference between the two.” It signifies the trust doctors have in regulatory authorities.
The generic manufacturer of eribulin will be conducting post marketing surveillance. Based on study reports quality of the generic drugs will be judged. However, with the launch of Eribilin, medical practitioners have an alternate to Halaven and can address the affordability factor making medication more accessible to more breast cancer patients.