When a copycat of Amgen’s Neupogen became the first approved biosimilar in the U.S. less than a decade ago, the competitive prospect of drugs that mimicked pricey biologics appeared poised to bring down drug costs.
Now, biosimilar makers are still fighting for even small slices of the patient population as the makers of branded drugs rake in the profits. For example, even as a new knockoff of AbbVie’s Humira hit the scene almost every month last year, payers often stuck with the branded product for a variety of reasons. Although Humira sales declined 32% last year, the drug stayed competitive through rebate-driven deals AbbVie struck with pharmacy benefit managers, according to a 2023 report from KFF Health News.
Still, Biocon Biologics, a subsidiary of India’s Biocon, has doubled down on its long-haul commitment to the biosimilars space. Some recent data supports that decision. According to a report from IQVIA, spending on biosimilars is expected to reach as much as $49 billion in 2027, and biosimilars for drugs like Rituxan and Avastin from Genentech and Herceptin from Roche have garnered more than 60% market share in their first three years after approval.
In 2021, the U.S. granted the first approval of an interchangeable biosimilar — the insulin glargine injection Semglee, a biosimilar of Sanofi’s Lantus — that could be substituted for the branded product at the pharmacy. Having partnered with Viatris on Semglee, Biocon Biologics in 2022 opted to purchase the company’s entire biosimilars program for more than $3 billion.
As a pure-play biosimilar maker with eight commercial products globally in diabetes, oncology and immunology, as well as upcoming programs in ophthalmology and bone health, Biocon Biologics competes with major companies that don’t give up ground easily.
“The real risk around this is when you have all the approvals and then things still don’t move. I can have the product and all the programs and launch with FDA approval, but I’m still fighting for 2%,” said Matthew Erick, chief commercial officer at Biocon Biologics.
‘Biosimilar first’
To promote more equitable competition, Erick believes healthcare policies should grant biosimilars better market position as they launch so that prescribers and payers understand and take advantage of the potential savings.
“We need to think about a ‘biosimilar first’ program for adoption, because if biosimilars come in and the innovator just lowers their price, like you saw with Humira, and biosimilars gain zero traction, that’s not good for the future because a lot of money was spent on those biosimilars,” Erick said. “We need to [ensure] biosimilars are supported as a viable entity not to take the branded people out but … continuing to introduce competition.”
A “biosimilar first” approach would motivate clinicians to opt for the biosimilar over an originator product for new patients.
“If we have biosimilars launching, and they still stay where the innovators have 98% [of the market], I don’t think you’re going to have biosimilars very long. It’s really tough thinking about the investments around that.”
Matthew Erick
Chief commercial officer, Biocon Biologics
Erick sees progress being made on that front despite the challenges.
“From our perspective, it’s about access and affordability … [but] today, it’s very confusing to the patient,” Erick said. “In the next five to 10 years, though, it will be successful — what I’m proud of is we’re seeing more affordability, the launch of more biosimilars, and they can add a lot of value.”
Even in areas where innovative biologics have accrued monumental success, biosimilars can thrive, Erick said. For instance, GLP-1 medications for diabetes and weight loss such as Ozempic and Mounjaro play an important role in improving health outcomes, but they’re not for everyone. And insulin biosimilars like Semglee can fill a gap for patients outside the GLP-1 bubble.
“As we’re seeing the shift not only in the U.S. but elsewhere with GLP-1s, someone has to be there to help the patients who maybe don’t qualify for that product yet, or can’t afford it because it’s not covered,” Erick said.
The main objective is to allow biosimilars a return on investment that would enable them to remain a viable option years down the road. Right now, that future is iffy, Erick said, pointing to industry giants who have backed away from biosimilars, including Pfizer and Biogen.
“If we have biosimilars launching, and they still stay where the innovators have 98% [of the market], I don’t think you’re going to have biosimilars very long,” Erick said. “It’s really tough thinking about the investments around that.”
Getting payers on board
Payers ultimately want to offer patients a drug that is proven to work but also fits an appropriate pricing model, which would appear to put biosimilars in a good position. But Erick often sees a slower commercial rollout for biosimilars than one would expect.
“Just because you win a formulary doesn’t mean you’ll get any pull through, so you have to go out and talk about your product, your patient assist programs, your patient co-pays, all the things you do to help the patient be compliant,” Erick said. “It’s very expensive, and it takes time, and this is why you see biosimilars slowly ramp up.”
Still, Erick is optimistic that biosimilars will play an important role in the future of prescription medicines. Payers are beginning to learn through launches of biosimilars for Humira and Stelara how to negotiate biosimilar entries from timing to cost, he said.
“Getting into 2025, we’re going to see some changes [to payers’ biosimilar adoption] — they’re more familiar with it and more understanding,” Erick said. “I firmly believe if it weren’t for biosimilars, we’d still be looking at the same diabetes prices [from] about a year and a half ago … and that shows you the progress biosimilars can make.”
