Frost & Sullivan Breaks Down Biosimilars Market
By Mia Burns (email@example.com)
Frost & Sullivan tracks the biosimilars market often, and the company recently hosted an analyst briefing about the pending transition of the market from a state of infancy to an entrenched facet of healthcare. In the interim, several biosimilars, or follow-on biologics, have been successfully launched in many countries outside the United States.
Lower cost biosimilar versions of more complex biologic therapies, such as monoclonal antibodies, are now eagerly awaited and expected to significantly impact healthcare costs, particularly in the United States, which is the largest market for biotechnology. However, Frost & Sullivan analysts say that residual uncertainties surrounding approval and commercial uptake could considerably influence the true potential of this market.
Deborah Toscano, senior industry analyst, pharmaceuticals & biotechnology, Frost & Sullivan said during the webinar that a greater number of players in the market as it becomes more defined. “The players will probably be a mix of both small biotechs and large companies with numerous partnerships between the two entities,” she told Med Ad News Daily. “In addition, many larger non-pharma companies are looking at biosimilars as a gateway into the growth opportunity that healthcare presents, and there are several partnerships already, such as the joint venture between Fujifilm and Kyowa Hakko Kirin. We expect to see more partnerships like this since biosimilars presents a unique opportunity to capitalize on biotech analytical capabilities without the need to invest in therapeutic research.”
The market is expected to open up and this is partially because of patent expirations. “As more biologics go off patent there will be more opportunities to penetrate, but also as the end-users get more accustomed to biosimilars their adoption will probably pick up, allowing the later entrants to capitalize on the earlier players having already set the market,” Toscano told Med Ad News Daily.
A few factors will lead to a more defined market. “A relatively clear pathway to market approval in different regions will be key, but also a better idea of how best to market biosimilars and educate end users will also help to shape the market,” Toscano says.
The FDA has yet to finalize its guidelines, and even once this occurs, uncertainty may remain as the agency would have to review each application on a case by case basis. Toscano said during the webinar that the final agency guidance is anticipated during 2014, with the first biosimilars being held in anticipation for some time in 2015.
Underlying reasons for the delay in final guidance from FDA are unknown, Toscano told Med Ad News Daily. “We don’t know for sure, but I think that it is just a very difficult position in that the FDA must above all else ensure patient safety, but at the same time encourage introduction of biosimilars for the sake of controlling healthcare expenditure,” she says. “There are many questionable factors that have to/had to be sorted out, such as how similar is similar enough (the most important question) in addition to things like naming conventions and labeling requirements. The clinical trial requirements must be such that the agency can be confident in the safety and efficacy of the product, which must be not clinically different from the reference product, including superior, while at the same avoiding unnecessary human experimentation. And since each biologic molecule is very unique in the way it is produced and how it behaves in the body, it is probably very difficult to lump all biosimilars under one general approval pathway, hence the FDA statement that they will review each molecule on a case-by-case basis.”
The U.S. market lags behind Europe and other counterparts. “The United States is definitely behind Europe and other regulated markets, and while Europe is a significant market as far as size, the United States is the largest and therefore most attractive,” Toscano says. “I think that the potential sponsors are probably quite impatient, but I don’t think the delay will compromise the market apart from delaying it. Biosimilar product experience in other regulated markets like Europe prior to introduction in the United States will help to prepare the U.S. market. And now with mandatory health insurance taking root in the United States, the need for lower cost biologic therapies is greater than ever, since there will likely be hundreds of thousands of previously uninsured people signing up with conditions like rheumatoid arthritis or cancers for whom biologic therapy was cost prohibitive. And although it may be the case that the biosimilar versions are cost prohibitive as well, for this we will just have to wait and see.”
Biosimilars sales and marketing are better left in the hands of big pharma, says Toscano. “Big pharmas are armed with large sales forces and a good deal of capital to put toward marketing expenses,” she told Med Ad News Daily. “Since biosimilars are such a new concept, a good deal of education will probably be necessary to boost confidence and encourage uptake. Small biotechs typically don’t have the resources to take a new product all the way to market, or even through late stage clinical testing.”
Posted: October 2013