Biocon Chairwoman Kiran Mazumdar Shaw On Global Biosimilar Regulations, Partnerships And Future Competition: An Interview With PharmAsia News (Part 1 of 2)

Biocon Chairwoman Kiran Mazumdar Shaw has been the face of the emerging Indian biotechnology industry for decades. Under Shaw's leadership, what started in Bangalore in 1978 as a small enzyme-manufacturing unit has transformed now into a promising enterprise with partnerships with large global companies like Bristol Myers-Squibb, Pfizer and Mylan. Shaw is known for her relentless pursuit to bring out cost-effective biopharma solutions and expresses optimism about the future of biosimilars. Fresh off a deal with Pfizer for insulins, Shaw spoke at length with PharmAsia News' India Bureau about the global opportunity and regulatory challenges for biosimilars and Biocon's recent dealmaking with Mylan and Pfizer.

PharmAsia News: Biocon forged an alliance last year for high-end biosimilars with Mylan. Who is responsible for regulatory filings in the U.S.? Will it be through Mylan or will Biocon take partial charge of that work (Also see "Biologics Beckon: Biocon, Mylan Strike Deal; Combine To Take Teva, Sandoz Head-on" - Scrip, 29 Jun, 2009.)

Kiran Mazumdar Shaw: Certainly, we will do the process in a joint way but Mylan by virtue of having far greater understanding of the U.S. regulatory systems - they will be shouldering that responsibility. Also that is the market that Mylan has always catered to. At the same time, we are working truly as partners where we are having brainstorming sessions with a number of consultants and experts on dealing with the entire process to ensure that we have a good clinical strategy in doing business there.

PharmAsia News: The clinical strategy for biosimilars will be a very vital part of doing business in United States?

Shaw: That applies to the whole business strategy to say the least. It has to be very well thought out, no doubt on that.

PharmAsia News: What gave Biocon the confidence to align with Mylan especially since Mylan had no great experience in even complex generic drug filings?

Shaw: I really don't know where this question is coming from. Mylan has been a very successful company in the U.S. and other parts of the world in marketing generics. In terms of biogenerics approvals, I think the approach broadly is going to be the same as generics. So, if we get the approvals for biogenerics, I think Mylan has the required clout in marketing the products and so I don't think there is going to be a difference in that.

PharmAsia News: How do you as Biocon or even Mylan intend to deal with the big question of interchangeability or substitutability for biosimilars in the U.S.?

Shaw: That is going to be a big issue but even in that case where substitutability is brought up as a question, Mylan has the wherewithal to deal with market needs for a product in the U.S. This is a big opportunity for all of us and wherever we can get a good cost differential between the innovator's product and a biosimilar, there will be avenues open for marketing and we are sure Mylan understands these issues very well.

After all, this is not about marketing an injectable or a tablet. This is about a good strategy because generics are very different from biosimilars. If you ask me whether Mylan can handle an innovator drug or how successful would they be, that will be a different question but on our set of products, I think they are very competent and they will be very successful.

PharmAsia News: How exactly would you handle the interchangeability issue anyways?

Shaw: Even if there is a question of interchangeability, Mylan will be a strong player in handling this. The question is how many companies could get an approval for their products. The whole biosimilars story according to me will be about the clinical strategy and the regulatory strategy and exactly how many players could there be in the market.

I believe it will be a big challenge in the first few years as there will be fewer players in the market. We can be one of the early entrants and therefore we will have a huge advantage with Mylan on our side. We in Biocon are very impressed with our partnership and the way Mylan is handling these programs. They are right up there.

PharmAsia News: So if there is a need to set up an independent field force to cater to that market, Mylan will do that ?

Shaw: This is not like selling diabetes tablets. These are all mostly hospital products and may not require very big teams or field force and so Mylan may be able to do it all very well. So, the products may be sold to an outside patient but it may be in a hospital setting.

Also I would like to digress a bit from Mylan here. What is important to recognize is that the healthcare reforms in the U.S. will have to look at areas like biosimilars differently from the present position. It is a huge challenge to address certain cost issues and if biosimilars can offer a better structure for them, it is undoubted that biosimilars can offer better medical outcomes. But right now, what is happening is that the cost-benefit ratio is prohibitive for innovator products and if that part can be addressed through lesser costs and better medical outcomes, it will be a great opportunity for the healthcare system.

In the U.S., a patient cannot be denied expensive drugs but if a recourse is available for a cheaper alternative, I think that will be an attractive opportunity. Although the lobbying to allow such possibilities will be very high, I think that a few of us could engage with the regulators to understand what are their concerns and if we can address those concerns, these products will be very important in the U.S. market.

PharmAsia News: Pfizer has also done a deal with you for insulin and its analogs. Can you comment on that deal particularly given that the exact regulatory pathway in the U.S. is still unclear [ (Also see "With Biocon Deal, Pfizer Expects To Gain First Mover Advantage In Global Biosimilar Insulin Market" - Scrip, 18 Oct, 2010.)]?

Shaw: Every Big Pharma is suddenly interested in doing deals in biosimilars and such products for the big opportunity. We are happy and proud to be partnering with a large company like Pfizer.

I do not think anybody is clear about how exactly the regulatory pathways are shaping up. There is a lot of ambiguity around this. If people are expecting bioidentical products, then there is a big problem. But if this is about biosimilars, we should talk about the acceptable and not acceptable points in terms of "biosimilarity." After all, safety and efficacy will be the biggest points. To me, biosimilarity will hinge largely on comparability in terms of safety and efficacy. That way, we have to show that biosimilars are absolutely comparable with the innovator drugs. And what gives us that confidence is that even in the case of the existing biotech drugs, we know that in a very general way, if you look at what most companies are producing as biotech drugs - whether there is a batch-to-batch variation or plant-to-plant variation - they are all biosimilars.

So you start with that premise that there is no company today that actually sells bioidentical products. Therefore if the same product is manufactured in two different locations, we know that they are not going to be "bioidentical." We are likely to see at least some variation in most cases because the fermentation process is so complex - the cell culture is so complex that there has to be variations and if there are multi-locational activities, in effect technically everyone is producing biosimilars.

But there are acceptable levels of variants and the question is, can we use the same yardsticks to develop biosimilar drugs? What leeway can be given to companies that are looking at biosimilars? To me the whole issue hinges on safety and efficacy. If these two points are comparable with the innovator drugs, which is about the immunogenicity, then I think we are talking about a simpler task when trying to make biosimilars.

PharmAsia News: But a few large biotech companies have raised doubts about the changing structure of the compound even if there is a minimal variation in the production lines?

Shaw: Those multinational companies should realize that in some ways, they are also selling biosimilars in a larger sense. I think every biotech company is selling a biosimilar because unlike chemical drugs where we have exact product specifications irrespective of where they are produced, we know that biotech drugs will have some variability in terms of there specifications. Glycosylation will have some variants if they are produced in two different plants.

In effect, I would like to use the concept that we are already using biosimilars in some ways - it is just the question of accepting the fact that even the present biotech drugs marketed are biosimilars. A change is very likely if the product is sourced from multiple locations. A few companies even acknowledge the variations from two sites, and that really is a question of debate.

- Vikas Dandekar ([email protected])

[Editor's note: Part two of this interview will appear in an upcoming issue of PharmAsia News.]