Humira, a name synonymous with swiss knife. It is a drug that could treat all conditions from Rheumatoid arthritis to Ulcerative Colitis.
It is a blockbuster drug that rose to prominence amidst challenges and strategic decisions. A journey worth looking back with a sleuth of biosimilars rising up.
It all began with a groundbreaking joint venture between Cambridge Antibody Technology and BASF in the UK, birthing the remarkable drug adalimumab, later known as Humira. Sensing an opportunity, Abbott Laboratories swooped in, acquiring BASF's pharmaceutical segment for a staggering $6.9 billion in 2000, aiming to fill their blockbuster drug void.
Abbott Laboratories faced fierce criticism from investment banks for lacking game-changing drugs in their pipeline. However, they placed their bets on Humira, recognizing its untapped potential. The drug braved rigorous clinical trials, emerging triumphant and earning approvals for multiple indications, including rheumatoid arthritis, psoriatic arthritis, and Crohn's disease in adults.
The triumph of Humira hinged on meticulous lifecycle planning. As Abbott Laboratories split in 2013, giving birth to AbbVie, the company doubled down on its investment in clinical trials, exploring new frontiers and expanding the drug's applications across a range of autoimmune conditions. The result? Revenues soared to unprecedented heights, thanks to the strategic vision of AbbVie.
AbbVie knew the importance of extending patent exclusivity, and they pursued it vigorously. Introducing innovative formulations and novel routes of administration, they introduced the game-changing Humira Pen, a self-injecting device. Furthermore, they ventured into Phase III clinical trials for additional indications, such as unspecified arthritis, peripheral spondyloarthritis, and pyoderma gangrenosum, expanding Humira's realm of impact.
Ever astute, AbbVie masterfully employed lifecycle management strategies. By conducting clinical trials for orphan indications with small patient populations, they earned additional years of exclusivity for these specific cases, even as other indications lost their coveted exclusivity status.
AbbVie's marketing prowess shone brightly in the success of Humira. They implemented a laser-focused strategy, targeting select physician specialties. By concentrating their efforts on rheumatologists and gastroenterologists, who could prescribe the drug for multiple indications, they maximized their impact while minimizing the burden of excessive visits.
While the initial US patent for Humira expired in December 2016, AbbVie unleashed the power of its patent portfolio. Leveraging newer patents for manufacturing methods and formulations, they extended the drug's exclusivity, safeguarding their market dominance. As European patents expired in October 2018, biosimilars began to emerge, poised to revolutionize the landscape, much like the expiration of biologics like Enbrel and Remicade.
AbbVie boldly employed a strategic maneuver known as "pay for delay." They struck deals with competitors like Amgen and Samsung Bioepis, compensating them for delaying the launch of Humira biosimilars in the US until a specified date. Although this approach came at a cost to AbbVie's revenue, it provided them with a clear roadmap for their future endeavors.
Yet no tale of triumph comes without its challenges. AbbVie faced scrutiny and criticism for its price increases, burdening patients and insurance providers alike. The escalating costs created hurdles, leading some patients to skip doses they couldn't afford. Government payers and insurance providers closely scrutinize the prices of high-cost drugs like Humira, compelling AbbVie to navigate these stormy waters with care.
As the curtains rise on the next act of Humira's saga, the entry of biosimilars promises a seismic shift in its market share. The stage is set for intensified competition, with lower-priced alternatives vying for attention. The impact of biosimilars will depend on various factors, including pricing strategies, physician and patient
The launch of Amjevita in the market early this year marked the beginning of a new era in the world of autoimmune treatments. Celltrion Healthcare announced the FDA approval of its adalimumab biosimilar, Yuflyma (adalimumab-aaty), making it the ninth biosimilar referencing Humira (adalimumab) to receive regulatory approval in the United States. Yuflyma is expected to be available in the market by July 2023.
ZoomRx conducted a survey with a panel of 30 Gastros and Rheums (Humira users) to understand their perceptions of the new biosimilars. Amjevita’s awareness grew from 63% to 77% in 5 months. Yuflyma’s baseline awareness is at 43% (20% lower than Amjevita’s).
When looking at the likelihood of uptake for the new biosimilars, about 2/3rd HCPs are a strong Humira preferers. A quarter of HCPs indicated no strong preference towards 1 product showing an opportunity for the new biosimilars. Most HCPs mention implementing a payer-dependent approach.
“Will promise lower cost for patients to be able to be treated who were not able to in the past”
“I expect insurance will mandate it.”
“Reason is that I suspect it will be preferred by the payer. It’ll be interesting to see over time, which biosimilar becomes a preferred product given the first to market advantage of Humira over the Biosimilar.”
“It's going to become so confusing with the multitude of biosimilars. It’s not going be a matter of preference, rather ultimately come down to cost and coverage“
“I'm going to view this much like I viewed the multitude of Infliximab biosimilars that emerged several years ago. I'll stick with the originator product until the payer suggest that I need to move in the different direction.”
Humira’s preference is mostly driven by HCP’s long-term experience and trust.
“Has been around for decades and supported by Abbvie, who is fantastic with their patient support.”
“Prefer Humira just like I prefer Remicade to Inflectra. Too early to tell - not enough clinical experience yet.”
“We talked about Humira and its delivery mechanism, concerned that other Adalimumab biosimilars primarily would not have the same ease of use that Humira has.”
Humira's journey from its inception to becoming a blockbuster drug has been a testament to strategic decision-making and relentless pursuit of innovation by AbbVie. The drug's success can be attributed to meticulous lifecycle planning, the introduction of innovative formulations, and an astute marketing strategy. However, the arrival of biosimilars brings a new chapter to Humira's story, challenging its market dominance. While physicians' strong preference for Humira based on their long-term experience and trust presents a hurdle for biosimilars, cost and coverage considerations may ultimately shape the landscape. As the battle for market share unfolds, patients, healthcare providers, and payers eagerly await the impact of biosimilars, hoping for more accessible and affordable treatments for autoimmune conditions.