The Biosimilars Outlook report notes that the discounts that were previously expected from biosimilars “have been significantly reduced” to between 70% and 80% of the cost of the branded biologic.
Celltrion’s recently approved Remsima, the biosimilar for Merck’s Remicade (infliximab), was used by the report as an example of one product expected to sell for 70% of the price of Remicade in South Korea.
But since some of the priciest biologics in the world can sell for hundreds of thousands of dollars for a year’s treatment, a 20%-30% price reduction may end up being quite significant in terms of cost savings. Biosimilar options for the top 12 categories of biologic treatments with expired patents would still save the US $67–$108bn over the first 10 years, and $236–$378bn over 20 years – an average of about $31bn a year, according to the study.
mAbs
Of the biologics with expiring patents, monoclonal antibodies “represent by far the most lucrative opportunity for biosimilars manufacturers, and this is reflected in the biosimilars pipeline as a whole, which is dominated by development programs for replicas of existing antibody therapies, primarily spanning the autoimmune disorder and oncology segments,” Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, told us.
“Adoption of biosimilars in the major markets such as the US remains tied to legislation changes to allow for biosimilar substitution, and indeed whether or not providers adopt these changes,” Owide said.
States are still grappling with whether to adopt legislation that either encourages or places new burdens on pharmacists and prescribers looking to biosimilars.
Slow Market Uptake
The savings over time may be enough to convince more companies to get into the biosimilar market, though pushback from biologics makers, especially in the US, as well as regulatory hurdles, may drive timelines for biosimilar launches back even further.
GlobalData notes that “many potential entrants are exercising caution in advancing their biosimilars programs.” In October 2012, Teva halted Phase III clinical trials of a biosimilar to Roche’s Rituxan (rituximab), and pulled the plug on its biosimilars JV with contract manufacturer Lonza. Similarly, Samsung also stopped its studies on the Roche monoclonal antibody. Roche is now saying it “does not anticipate that a rituximab biosimilar will appear on the market before 2016, three years later than its initial expectation,” according to GlobalData.
Moody’s also noted recently in a report that Roche, Amgen and Abbvie will be the most exposed to biosimilar competition.
No company has more to lose than Abbvie -- which intends to “aggressively defend” about 200 patents on the world’s top-selling blockbuster Humira before they come to end in 2016, according to GlobalData. Oncobiologics on Thursday announced the beginning of a Phase I trial for a biosimilar to Humira.
GlobalData notes that most deals now are focusing on “tapping into the significantly untapped South Asian and South-East Asian biosimilars markets.”
“Once companies have completed the necessary clinical studies for their biosimilar programs, and the therapies they are seeking to replicate lose data exclusivity, there should be a clear path for biosimilar uptake within some channels of the US healthcare system,” Owide added.