For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics.
As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
Meanwhile, CDER approved a dozen new biologics last year. That’s lower than the number greenlighted in each of the previous two years, but it’s double the new biologic license applications (BLAs) CDER was approving in the first few years of the decade. (See CDER BLA approvals.)
The biosimilar approvals will set up competition among the follow-ons themselves, as each of the seven biologics referenced in the 2019 approvals had at least one biosimilar previously approved. For instance, three of the 10 new biosimilars referenced Roche Holding AG’s breast cancer drug, Herceptin (trastuzumab), which already had two biosimilars.
Two new Humira (adalimumab) biosimilars also were approved last year, giving Abbvie Inc.’s mega blockbuster drug five competitors waiting to take it on. While licensing agreements will keep the Humira biosimilars off the U.S. market until 2023, the Herceptin follow-ons started launching last year. What happens in that space in the next few years could give some insight of how biosimilar competition will play out for other biologics once their key patents expire.
Given the 12-year exclusivity novel BLAs have under the Biologic Price Competition and Innovation Act, those approved last year won’t face biosimilar competition until 2031 – unless Congress shortens that exclusivity before then.
In removing a proposed 10-year exclusivity from the U.S.-Mexico-Canada Agreement (USMCA), the Trump administration provided an opening for reducing the biologic exclusivity in the U.S. A bill to implement the agreement already passed the House, and the Senate Finance Committee voted 25-3 Monday to send it to the full Senate for passage.
Regardless of the length of exclusivity, the future of biosimilars depends on a robust market for biologics, which really started coming into their own at the turn of the century, with 98 novel biologics being approved this past decade.
Due to the cost of biosimilar development and marketing hurdles, many of those biologics are unlikely to see biosimilar competition. So far, most of the biologics targeted to date by U.S. biosimilars have had peak sales above the $6 billion mark, according to Cortellis.
The 2019 class of novel biologics includes some that could fit that profile. For example, Abbvie’s new immunology drug, Skyrizi (risankizumab), is expected to have annual sales of nearly $4.15 billion by 2025, according to Cortellis. In comparison, Humira, approved in 2003, garnered $5.5 billion in sales in its seventh year on the U.S. market, and it hit peak sales of $20.3 billion in 2018. (See Novel biologics approved in 2019.)
One of the other novel BLA approvals – Roche’s Herceptin Hylecta (trastuzumab and hyaluronidase) – could open the door in the future to Herceptin biosimilars following their reference biologic’s lifecycle path through new formulations and combinations.
Although the number of novel biologics approved in 2019 was down from 2017 and 2018, biologics made up 25% of the 48 new molecular entities CDER approved last year. In 2018, a record-breaking year for novel drugs, 17 – or nearly 29% – of the 59 novel drugs CDER approved were biologics.
The biggest difference between 2018 and 2019 was a drop in the approval of orphan drugs, be they small molecule or biologics. CDER approved 21 orphan drugs last year compared with 35 in 2018. Despite the drop, those 21 drugs for rare diseases still accounted for 44% of the novel drug approvals last year. (See Orphan drug approvals this decade.)
That’s “a significant increase in CDER’s orphan drug approvals compared to earlier years,” CDER Director Janet Woodcock pointed out. She added that “in the past eight years, CDER has approved more than twice as many orphan drugs than we did in the previous eight years.” From 2012-2019, CDER approved a total of 142 novel orphan drugs as compared with 63 from 2004 to 2011.