Guest column by Christopher Ward published in Apothecurry
June 20, 2013
For generic dug manufacturers in India and elsewhere the number of blockbuster drugs that have recently come off patent has been a bonanza. But the product mix coming off patent over the next three years is dramatically different to the small molecule blockbuster drugs that dominated patent expirations in 2012. This presents a problem for them.
Beginning in 2013 and continuing through to 2015 many of the major patent expirations are biologic drugs. Indeed, in 2015, biologic drugs representing $10 billion in annual sales will constitute nearly one third of the drugs coming off patent. Unlike the blockbuster small molecule generics, generic biologics or biosimilars are not bioequivalent to originator products.
The importance of this difference cannot be overstated. In contrast to small molecule drugs, it is difficult and costly to demonstrate that a generic biologic is interchangeable with an originator product, and the safety and efficacy of the generic copy is required to be proven through clinical trials in developed markets.
This is because the safety and efficacy of a biosimilar is highly dependent on the method of manufacture and formulation, with minor differences potentially resulting in serious consequences. Essentially, small molecule drugs are made from chemicals and have simple and well-defined structures, whereas biologic drugs are produced in living cell cultures and tend to be unstable and difficult to control.
Long and arduous process
To date no interchangeable biologic drug has ever been approved by the US FDA. There is no doubt that this will change as drug plan payors in the established markets in the US and elsewhere begin to demand it, but building the market for a biosimilar will nevertheless be a long and arduous process.
Doctors will not automatically switch to prescribing a biosimilar when an original biologic drug comes off patent. Instead the gradual switch to biosimilars will be primarily for prescriptions for newly-diagnosed patients. In fact, a recent survey of US physicians found that 85% would be reluctant to switch their patients from an originator biologic drug to a biosimilar.
This does not mean that follow-on biologics are unsafe but rather that if a patient is responding well to the originator biologic, few physicians will take the risk of moving patients to a drug that is not identical.
Indian biosimilars leadership doubtful
Although India has announced a pathway for biosimilar approvals, there are currently three major impediments to India becoming a leader in this field. Firstly, India faces strong competition, particularly from South Korea, which is currently the global leader in biosimilar development in terms of trials and drugs in the pipeline.
Secondly, many of the major innovative companies will start leveraging their existing clinical research capabilities to develop biosimilars of competitors’ products, thereby blurring the lines between innovative and generic companies.
And finally, although India is blessed with a highly educated population and world-class expertise in manufacturing quality pharmaceuticals, it currently lacks the capacity to provide the oversight and regulation that biologic medicines require. In order to penetrate the biosimilars market in the West strong clinical research capabilities including clinical trials are necessary. But clinical research in India has lately been seriously hampered by a weak and chaotic regulatory system.
Recently, during a high profile court case, health activists alleged that clinical trials take place in India without the informed consent of participants and without proper state scrutiny. Media reports in India have also consistently emphasized a lack of drug regulatory oversight capacity. According to one report, India has only 124 drug inspectors in place to oversee 10,500 drug manufacturers throughout the country.
The potential for the uptake of Indian biosimilars in developed markets is therefore limited, if not non-existent, unless clinical research oversight and regulation are significantly improved. Under current circumstances, regulators in established markets will not approve Indian biosimilars, physicians will not prescribe them, and patients will not risk taking them without proof of safety and efficacy.
Recognizing these challenges many major Indian pharmaceutical companies have established joint ventures and partnerships with foreign multinational research-based pharmaceutical companies. In the future, they may well look to shift their biologic drug making capabilities to manufacturing facilities in North America and Europe.
India possesses many competent world-class researchers and its pharmaceutical majors are more than capable of producing top-quality generic blockbuster drugs. However, without serious regulatory reform, the best days for the Indian pharmaceutical industry may already be behind it.
This is a condensed summary of an article that first appeared in the May edition of Pharmaceutical Executive Global Digest and the second in a two part-series on the Indian drug industry’s growth prospects in western markets. The views expressed are entirely those of the author.
Christopher Ward is Senior Partner, World Health Advocacy, a health policy and communications consultancy based in Hamilton, Canada, and Washington DC. USA. World Health Advocacy clients include governments, civil society organizations and health industries including pharmaceutical companies. Mr Ward served for many years in elected office in Canada. In the Ontario Legislature he served as Parliamentary Assistant to the Minister of Health and was responsible for carrying the legislation that established the Ontario Drug Benefit Program, which remains the largest publicly funded drug plan in Canada. Subsequent to his service in the Ministry of Health he became Minister of Education and later Government House Leader. From 2008 to early 2013 Ward worked for PhRMA in Washington DC where he was responsible for international stakeholder outreach programs.