On April 17, Cipla launched its first biosimilar drug in India. The product is Etacept, a branded biosimilar of Pfizer’s Enbrel (etanercept).
The drug treats rheumatoid arthritis (RA) an autoimmune disease that leads to painful and debilitating inflammation, predominantly of the joints, and is estimated to impact 0.7 per cent of the Indian population above the age of 16 years. Cipla imports the biosimilar from a Chinese company. While Cipla’s launch was muted – a quiet press release – the development is worth a closer look. Here are some key takeaways.
Price drop not token, yet not exactly disruptive
Cipla’s Etacept will retail at Rs 6150 per 25 mg dose of the drug which is 30 per cent lower than Enbrel’s Rs 8700 per dose besides being a tad less than the Rs 6525 per dose that Pfizer charges under a patient assistance programme. Patients inject two doses per week.
One has come to expect drastically-reduced pricing from Cipla generics. In that light, a 30 per cent reduction, at first glance, does not impress. While it is widely expected that biosimilars will not be as discounted as generics (given their complexity and investment requirements) Cipla’s reduction -in percentage terms- is still at the lower end of the 30-50 per cent range generally expected from biosimilars.
“Biosimilars manufacturing and R&D is a lot more complex than standard chemical molecules,” said Cipla’s medical director Jaideep Gogtay in a telephone interview. Globally studies have suggested that those who respond well to the full dose of etanercept can be moved to half the dose after six months of treatment thus reducing cost, he added
However, whether doctors choose to act on this information is not in Cipla’s control. Also not in its control currently are the costs of producing the drug - this is a simple purchase-and-sell agreement with the partner- which might also explain the price point.
Will Pfizer follow suit?
Cipla’s biosimilar still entails a not-insignificant saving – of Rs 2550 per dose – for patients. But it is not beyond Pfizer’s reach to match pricing if it so wishes. Enbrel has been on the Indian market since 2004 with no biosimilar competition.
Whether or not Pfizer follows suit depends on how much it expects to lose.
Pfizer’s existing patient base may not be impacted. Cipla does not recommend that patients who can afford Enbrel and are stable on it move to Etacept, said Gogtay, and nor would doctors want that. “Those who can afford it and are happy (with it) may not want to change,” he said. “But the ones on the borderline who have stopped taking it because of the price may get on to it.”
It is estimated that 0.7 per cent of the Indian population over the age of 16 years has RA though it is anybody’s guess how many are diagnosed and treated. Of those treated, 60 per cent manage RA with branded generics – such as a combination of methotrexate with leflunomide – while the balance need add-on biologics such as Enbrel and Johnson & Johnson’s Remicade which also sells in India.
Curently, just 5 per cent of RA patients who need biologics are taking them, Gogtay says.”If only one patient a week was getting on to Enbrel, two patients a week might take (Cipla’s) biosimilar.”
In other words, there is potential for growth and it is this that Pfizer will lose if Cipla is able to convince doctors.
Doctor acceptance is key
Putting a number to that may be difficult. (Cipla hopes for a 30 per cent volume expansion in year one). A lot will depend on rheumatologists’ acceptance of Cipla’s biosimilar. Unlike generics that have whole-hearted acceptance, some doctors have been wary of biosimilars given their complexity and that the smallest changes in manufacturing process can alter the results.
“The key is that the bio-similiar should be shown to have a similiar clinical and efficacy profile with comparable (if not better) toxicity profile to the parent biologic, in clinical trials,” said Dr S J Gupta, senior consultant rheumatologist at Apollo Hospitals, New Delhi in an e-mail response. He said that while he was aware that Cipla had a biosimilar of Enbrel he had yet to see the data on it.
Pfizer reps can, if they choose, harp on the fact that Cipla’s Etacept has not been approved under the new biosimilar guidelines made by the government last year but under the rules that were written with generics in mind. Casting doubt on the safety and efficacy of biosimilars is a well-worn innovator tactic to discourage prescription.
Chinese data
As far as India-specific data is concerned, Cipla’s is currently limited to a 104-patient phase three study of safety and efficacy which is mandatory under Schedule Y of the Drugs and Cosmetics Act for any new drug. However, Shanghai CP Guonjian Pharmaceuticals, the Chinese partner from whom it purchases the drug, has furnished clinical trials data from phase one to three on several hundred Chinese patients which was shared with the Indian regulator, Gogtay said. Cipla also intends to conduct post-marketing surveillance and submit periodic safety reports to the regulator, he said.
Shanghai CP made the drug available in China five years ago and it has been used by over 50,000 RA patients, said Gogtay. It is currently also retailing in Colombia and awaiting registration in Brazil.
Comfort levels
Thanks to launches from Indian, Korean and Chinese firms, Indian doctors are now well-acquainted with biosimilars though they may not all prescribe them. “Biosimiliars do offer an advantage in terms of economic considerations; one example is ‘Reditux’ which is a rituximab bio-similiar, brought out by Dr Reddy’s Lab,” said Apollo’s Dr Gupta. “It has been in use for a few years, has proven to be effective and is about 45 per cent cheaper.” Rituximab is a biologic by Roche that is used to treat RA and some cancers.
He added that “the main barrier to biologics being used and accepted by patients (even though they may be prescribed by the treating rheumatologist) is cost,” though some may be deterred by the injections and the thought of side-effects.
When asked if it would match Cipla’s prices, a Pfizer spokesperson in an e-mailed statement referred to the patient assistance programme as an example of making Enbrel affordable and added that “Pfizer will continue to develop strategies where both access and innovation needs are suitably addressed.”
In the meantime, Cipla’s work is cut out.
Pic courtesy photostream of Sterile Compounding on Flickr
This post was corrected to attribute quotes that appear under the final sub-head to Dr Gupta. Attribution was inadvertently left out. The author regrets the error.
