Dive Brief:

• Samsung Bioepis and Biogen on Wednesday said the Food and Drug Administration accepted a filing seeking approval of their copycat version of the widely used eye treatment Lucentis.
• If approved, SB11 would become the first biosimilar version of Lucentis, potentially offering a more affordable option for the many people who suffer from retinal vascular disorders. European regulators began reviewing the drug last month.
• Roche currently sells Lucentis in the U.S., while Novartis markets it in other countries. In the third quarter, the product brought in sales of 392 million Swiss francs, or about $430 million, for Roche and $515 million for Novartis.

Dive Insight:

Samsung Bioepis and Biogen aim shake up a market worth billions of dollars. Novartis said sales in its ophthalmology business, including Lucentis, reached $1.2 billion in the third quarter. Regeneron also has a top-selling drug called Eylea, sales of which topped $2 billion in the period.

Biogen earlier this month announced it was expanding its efforts with Samsung Bioepis to include Lucentis and a biosimilar for Eylea. Biogen owns a 49.9% stake in Bioepis, a joint venture with Samsung Biologics.

With four FDA biosimilar approvals under its belt, Samsung Bioepis is a leader in the expanding market for biosimilars. Biogen sells three of those products in Europe, copycat versions of the blockbuster immune drugs Humira, Remicade and Enbrel.

Recent earnings show biosimilars have become a substantial part of Biogen’s business. Sales of three copycats totaled nearly $800 million over the past four quarters.

Samsung Bioepis is also developing biosimilar products with Merck & Co., which sells the company’s copycat version of the cancer drug Herceptin in the U.S.

There, the biosimilar market is still relatively new. The FDA approved the first biosimilar for the U.S. market in 2015 and to date has only cleared 28 copycat biologic products. Many of those drugs aren’t available yet, due to patent litigation that has prevented commercial launches in the U.S.

So far, the discounts offered by biosimilar versions of expensive biologic drugs have been relatively modest, ranging from 10% to 35% less the list price of the branded product. Generic versions of pharmaceutical medicines, by contrast, can be as much as 95% cheaper than their branded competitors.