4 takeaways about the U.S. biosimilars market
When President Obama signed the Patient Protection and Affordable Care Act in 2010, the stage was set for the emergence of an active biosimilars market in the U.S., including support for creating a well-defined pathway to approval. Four years later, the U.S. still does not have that pathway, but companies are moving biosimilar products -- biopharmaceutical drugs with active properties similar to ones already licensed -- through clinical trials.
Currently, there are about 25 biosimilar products being evaluated by FDA, and based on the current landscape, it seems inevitable that within the next five years, biosimilars will be become a regular go-to treatment option.
Here are some questions and answers about the emerging biosimilars market:
Where are we now?
Admittedly, it has taken the biosimilars market a while to develop and come into its own in the U.S., especially compared with Europe and India, which both have relatively well defined regulatory pathways. However, that’s rapidly changing as companies like Sandoz (part of Novartis), Boehringer Ingelheim (BI) and others start to move into submit biosimilar products for evaluation and formulate launch strategies.
The incentive to develop in this space is strong. The top-selling drugs worldwide, including Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab), are biologics and there is vocal demand for cheaper biologics-based treatment options.
What are some of the companies actively pursuing the biosimilars market?
There are quite a few, including Ratiopharm (part of Teva), Pfizer, Merck, Biogen Idec, and others. BI is a good example of a company that will soon be launching a biosimilar. According to a report from Biosimilar News, published in April, BI currently has several biosimilars in development for several biologics, including Humira (adalimumab), Avastin (bevacizumab), MabThera/Rituxan (rituximab) and Lantus (insulin glargine). It also has the advantage of having experience as a contract manufacturing organization heavily involved in biologics manufacturing.
At this moment, BI’s most advanced biosimilar product in terms of the development timeline is Lantus, which should be launching in 2015. Though Lantus will most likely be the first biosimilar to come to market, BI is looking to its version of Humira—the top-selling drug in the world with $10.7 billion in revenues in 2013--- as a potential source of substantial revenues. Humira loses patent protection in 2016. In fact with multiple indications for chronic conditions—rheumatoid arthritis, psoriatic arthritis and Crohn’s disease---Humira is a likely target for many other companies as well.
What are some of the challenges facing companies attempting to develop biosimilars?
There are many challenges, including the previously mentioned lack of a well-defined regulatory pathway to approval.
Compare that with the experience of Dr. Reddy’s, an India-based company, which received approval for biosimilar rituximab in 2007. With abbreviated pathways and regulatory authorities that regularly review biosimilars (or follow-on biologics as they are referred to in some markets), both India and Europe provide much easier entry into the biosimilars market.
Nonetheless, one reason that this has been so challenging is because of stringent clinical requirements. The Biologics Price and Competition Innovation Act (BPCIA) requires that all biosimilar products provide the same clinical results in every patient tested as the reference biologic product -- without increased risk or decreased safety.
There is also the issue of cost. According to IMS, the cost associated with developing a biosimilar product is between $100 million and $250 million. While that is less than the cost of developing a new small–molecule drug, it is substantially more than the cost of developing a small-molecule generic, which costs between $1 million and $4 million. Finally, there are issues associated with physician uptake and acceptance, a process that will simply take time.
What’s the good news?
There is a lot of it — for manufacturers, healthcare practitioners, payers and patients. The biosimilars market is being driven by cost pressures, and the advent of biosimilar options will shift down the treatment costs associated with many autoiummune diseases, as well as cancer and other conditions. As experience builds and regulatory approval of biosimilars becomes standard practice, the U.S. will become a much larger part of a market that is quickly approaching $2.5 billion in revenues. It’s just a matter of time.