As aging blockbusters come off patent, new opportunities emerge for biosim manufacturers
- In a new report, IMS Health predicts biosimilars will play an increasingly important role in the global biologics market as major drugs lose patent exclusivity and new biosimilar versions come online. This could result in cost savings of up to $110 billion in EU and US markets through 2020.
- While focusing on the cost implications, the report estimates there are nearly 50 distinct biosimilars currently in development which could enter the market over the next five years. This will not only ramp up the competition among biosimilar drugmakers but will also create new opportunities for drug manufacturing across markets.
- The report highlighted the need for more consistent messaging on biosimilars from manufacturers. According to IMS, disagreement around the issue of substitution has held back movement toward an agreed set of principles for payers, physicians, and manufacturers.
Many biosimilar manufacturers are targeting the same four biologics: Humira, Remicade, Enbrel, and Mabthera. In total, there are 41 biosimilars in preclinical, early, and late stage testing for these four drugs.
Samsung Bioepis has grabbed an early lead, filing with the European Medicines Agency for a biosimilar version of Remicade and winning EU approval for its biosimilar Enbrel, marketed as Benepali. It is also in phase 3 for a biosim version of AbbVie's top-selling Humira.
The company was able to speed up development of Benepali by procuring a large supply of originator product, as FiercePharma Asia reports. This enabled it to hone in on matching key parameters of the originator with the copycat version.
There is significant value to be won as these blockbuster biologic drugs come off patent. IMS estimates the combined value of the top 8 biologic medicines losing exclusivity between now and 2020 to surpass €42 billion. Payers are paying close attention to this as the switch from branded biologic to biosim could lead to substantial savings at a time when budgets have been squeezed by costly drugs.
"By competing with original biologic medicines across a growing range of therapy areas, biosimilars offer stakeholders -including payers, physicians, and patients - greater choice when it comes to treatment options," the report said.
However, the substantial variation between countries in their approach to biosimilars could limit opportunities. Payer policies across Europe differ, as does the willingness of countries to motivate manufacturers to participate in the marketplace.
In particular, the report highlighted the inconsistent rules on the interchangeability of biologic medicines with biosimilar copies. This creates confusion for physicians who are unsure when to switch patients off of a branded biologic.
Differing rules on interchangeability and labeling could also create an uncertain environment for assessing liability. Wheres generic versions of pharmaceuticals are bioequivalent, biosimilars are highly similar versions of a reference product. Since there are (permitted) variations between the drugs, biosimilar producers could be exposed to different liabilities.
- Regulatory Focus IMS: Biosimilars Could Save Up to $110B in EU, US Through 2020
- FiercePharmaAsia Samsung Bioepis offers a glimpse at biosimilar manufacturing prowess
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