Interview by: Sulastri Kamis
One person’s loss is another person’s gain.How apt the saying goes for pharma companies dealing with biosimilars and generics in the wake of patent cliffs that began in recent years. As the Big Pharma sees sales revenue falling, companies dealing with biosimilars are gaining momentum.
As biosimilars are predicted to have increased sales, will we be seeing a similar increase in generic drugs in 2013? EvaluatePharma has determined that in 2013, patents will expire on drugs that currently have sales of $29 billion annually. The research firm expects more than 70% of that total will be lost to generics.
Yes, sales of generic drugs will increase in 2013 as patents expire on branded medicines, resulting in lower-cost generic versions being made available to the market. Governments, regulators and payers are all looking for ways to slow the growth in health care spending and realize more value from prescription therapies, both branded and generic.
Why is there (seemingly) a gaining popularity in biologics/biosimilars over chemically synthesized drugs (generics)?
Biologics/biosimilars are favored because they are revolutionizing modern medicine in a number of ways. Firstly, biologics/biosimilars are targeted to specific receptors and have a specific mechanism of action, thereby providing treatments for complex diseases. This allows health care providers to target better biologics/biosimilars for use with patients who will benefit. Secondly because biologics/biosimilars are satisfying therapeutic needs that were not being adequately addressed by chemically synthesized drugs.
You predicted that insulin and interferon (INF) Alpha will not be approved as a biologic in 2013 despite the European Medicines Agency recognizing all 14 biosimilars existing currently. In your opinion, what would it take for insulin and INF Alpha to be accepted as biosimilars?
What is needed is the identification of a molecule that is biosimilar from both the safety and efficacy standpoints.
How far away are we from it? In your opinion, why is it important to identify such a molecule despitethe current presence of pharmaceutical forms of interferons and insulin for therapeutics?
This is something that is not possible to determine at this point in time based on data available.
It is important to identify a molecule that is biosimilarbecause the entire concept of biosimilars is important, particularly in bringing the price of biologics down so they can be accessible to larger populations of patients who need them but cannot afford them.
India has been particularly strong in the generics industry. With predictions looking towards biosimilars, would this have a strong impact on India’s generics industry?
Generics and biosimilars are fundamentally different. We do not see a direct correlation between the growth rate of generics and biosimilars and expect each to progress at their own rate.
We’re seeing more and more of the Big Pharmas down-sizing and moving operations to Asia with an increase in co-operations with CROs such as Quintiles. Other than out-sourcing clinical trials and relocation, do you foresee any other moves the Big Pharma might make in the near future?
The trend toward strategic partnerships – in which all parties involved operate on a peer-to-peer basis and share risks and rewards – will continue to accelerate. This is far different that traditional outsourcing in which qualified vendors are asked to bid, with the winner usually being the lowest bidder. Large multinationals are now looking for partners who can add the greatest value, and bring expertise and unique insights to the table. Crucial to this trend is the selection of partners who can manage data with the alliance – turning it into knowledge that drives faster, better decision making. That process has already begun. More and more of our customers are seeing the value delivered by out Quintiles Infosario™ platform, which integrates data, systems, processes to offer real-time transparency about how their studies are progressing and informs decision-making. That’s one mega-trend we see – the willingness of big pharmaceutical companies to share expertise and data on a peer-to-peer basis with strategic partners.
Any comments on biologics and patents set to expire in 2013?
For every biologic that is coming off patent, activity has started to replace them with biosimilars and we expect this activity will escalate in 2013.
About the Interviewee
Dr. Rebuck heads up the Strategic Drug Development unit of Quintiles in Asia where his team guides clinical and regulatory strategies for clients wanting to develop their medicines in Asia. Previously, he held senior leadership positions in GSK and Pfizer. He was formerly Professor of Medicine at the University of Toronto and a respiratory medicine specialist at the Toronto Lung Clinic.
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