Indian firm Cipla has announced the launch of its etanercept product in India.
IHS Global Insight perspective | |
Significance | Indian firm Cipla has launched a biosimilar etanercept product in India. Etacept, manufactured by Shanghai CP Guojian (China) is approved for the treatment of various rheumatoid conditions. |
Implications | The approval marks the first etanercept biosimilar to be approved in India. The new drug is being offered with a 30% discount over the brand, bringing the cost of treatment using etanercept significantly down. |
Outlook | The potential market size for Etacept is likely to be limited by the fact that even at a discounted cost against Enbrel, the cost of biologic treatment is out of reach of the majority of the Indian population. This may necessitate the development of a patient-assistance programme to drive uptake, especially in the initial stages of market entry. |
Indian company Cipla has announced the launch of a biosimilar etanercept product in India. The biosimilar will be marketed in India under the brand name Etacept. Etacept, produced using recombinant DNA technology, binds to tumour necrosis factor-alpha. Etacept, administered by subcutaneous injection, has been approved in the treatment of a number of rheumatic disorders including rheumatoid arthritis (RA), ankylosing spondylitis, juvenile idiopathic RA, and psoriatic arthritis. It remains likely that Cipla has used Enbrel (etanercept) manufactured and marketed by US firms Amgen and Pfizer as its target; however, this has not been specified in the company press release. A copy of the company press release can be accessed here.
Cipla's Etacept comes from a partnership with Chinese firm Shanghai CP Guojian Pharmaceutical Co. Ltd (CP Guojian). Under the terms of the agreement between the two companies, CP Guojian undertakes the manufacturing of Etacept, with Cipla marketing the product. It remains unclear if Cipla has exclusive marketing rights in India. CP Guojian reportedly launched its etanercept product in China in 2005 under the brand name Yisaipu. Since its launch, some 50,000 patients have received treatment.
In terms of pricing Etacept is being offered to patients at a price of INR6,150 (USD113.53) per 25-mg dose; patients typically require twice-weekly doses. This pricing, according to company-reported data, means that Etacept could be priced 30% lower than the innovator. In addition to being cheaper, clinical studies of Etacept have reportedly suggested that a dose of 50% of that currently used may be provide similar efficacy in treatment.
Outlook and implications
The announcement of the successful approval and marketing of CP Guojian's product in another major international market is likely to be seen as adding legitimacy to the product. With CP Guojian seeking partners for the launch of its various biologics in other international markets, the approval of the product in markets such as India is likely to strengthen its efforts to seek out these new partners.
This said, it remains unclear on what basis and using which pathway the biosimilar was approved in India. According to the Indian Clinical Trial Register, Cipla conducted a Phase III non-comparative trial to evaluate the efficacy and safety of an etanercept product. This would suggest that Etacept was not compared with Enbrel, leading to the potential that some might consider Etacept to be considered a "non-innovative biologic", i.e. an intended copy of a biologic but without demonstrated similarity to the reference product, as opposed to a "biosimilar". A link to the Indian clinical trials registry can be accessed here.
Despite the cost savings associated with Etacept over current biologic medicines, even with the improved pricing, given that a high proportion of drug expenditure is out-of-pocket and insurance coverage is low, Etacept is likely to be out of reach of the majority of Indian patients. Compounding the size of the potential market is brand loyalty, which may drive those who can afford it to purchase Enbrel. The limited ability of many patients to afford even the cost of biosimilars has driven other Indian companies to employ patient-assistance programmes; for example, Dr. Reddy's employed a patient-assistance programme to drive uptake of Reditux (rituximab).
Cipla's potential market will also be affected by competition from other Indian companies, with domestic firm Biocon currently developing a biosimilar etanercept that is in a pre-clinical stage of development, according to company-reported information.