Biosimilars scorecard: 700 products in development; 245 developers

Using such resources as Cortellis Competitive Intelligence, Newport Premium and the company’s own Life Sciences Professional Services, Thomson Reuters Bioworld (Philadelphia) has issued a new report tracking the development of biosimilars globally. Entitled “Biosimilars: A Global Perspetive of a New Market—Opportunities, Threats and Critical Strategies 2014,” the report finds that South Korea is a “notable standout” for its ambitious development programs; India is also very active. There are 245 companies or research institutes worldwide pursuing development programs. Like drug development generally, however, it remains to be seen how many programs will be able to run the course all the way through approval, especially for the US market where FDA is still assembling its approval program.

According to Thomson Reuters:

• Big pharma and generics makers face a steep learning curve: While generic makers currently lead the pack, the expertise in this market is held by the biologics makers. New pure-play biosimilar makers funded by governments and private investors also have a strong presence in this arena.
• Biosimilars promise to deliver big savings: Typically offering 20 to 30 percent discounts from innovator biologics, biosimilars are expected to deliver $11 billion to $33 billion in savings across the European Union (EU) by 2020.
• Lower-prices: Slow market uptake of biosimilars in the EU may not also hold true for the U.S. Unlike most of the EU, the U.S. will allow interchangeability, which is expected to speed adoption and lead to lower prices.
• A level playing field: The World Health Organization recently proposed a voluntary, global naming scheme that could level the playing field for biosimilars and their reference biologics.
• Accessible treatment: In many parts of the world, follow-ons offer new hope to patients who previously did not have access to pricey biologics, bringing the power of biologics for the first time to markets in Africa, Asia, Eastern Europe and Latin America.

“Governments and payers are counting on biosimilars to dramatically change drug development and patient costs by reducing the price tag of important biologics and increasing access to life-saving drugs," said Jon Brett-Harris, managing director of Thomson Reuters Life Sciences. "For this to happen, biosimilars must deliver the power of the reference drugs at a price developing countries can afford and gain the confidence of the marketplace. They have to create their own market."

Details on the report are available here.