Implications of the AVT02 (Humira Biosimilar) by Teva and Alvotech on the Humira Biosimilar Market

The pending second Biologics License Application (BsUFA) for AVT02 (Humira biosimilar) by Teva and Alvotech, on June 28th, 2023 (Today), could dramatically alter the dynamics within the Humira biosimilar market. Anticipated approval of AVT02 by both companies introduces heightened competition, price pressures, and an upheaval of market share. This shift holds immense potential in benefiting patients, healthcare systems, and payers by offering a more affordable and accessible alternative to the reference biologic. Consequently, this development could leave a permanent imprint on the inflammatory disease treatment landscape as the biosimilar market continues to mature.

Biosimilar Market Dynamics

Although biosimilars attracted significant attention a year ago, their current market focus appears to be somewhat diminished. In the previous summer, Teva set its Long-Term (LT) target aiming for Mean Standard Deviation (MSD) revenue growth by 2027, majorly banking on the biosimilar pipeline. This pipeline consisted of five programs targeting an estimated $40B in branded sales, including bHumira (BSUFA 6/28).

According to IQVIA, the global biosimilar market is predicted to grow at a 16.8% Compound Annual Growth Rate (CAGR) from 2022 to 2027, escalating from $26B to $56B. Yet, at the recent Investor Day, Teva announced plans to decrease its biosimilar Research and Development (R&D) budget by up to half, dropping from 20% in 2022 to 10-20% in 2027. The contribution of biosimilars to growth appears significantly lower than that of innovative products, a surprising shift given the substantial Loss of Exclusivity (LOE) opportunity and Teva’s pipeline.

Potential Challenges

This market shift is possibly due to challenges faced by manufacturing partner Alvotech and the confusing pricing dynamics in the bHumira market. In 2020, Teva entered a partnership with Alvotech on five U.S. biosimilar programs, including Humira, Stelara, and Eyelea. However, this journey towards bHumira approval has not been smooth, with troubles at Alvotech’s Iceland facility resulting in two Complete Response Letters (CRLs) and another BSUFA date looming just days before the initial 7/1 launch target.

Moreover, intriguing pricing strategies from AMGN and CHRS (which Abbvie challenged) have surfaced. While it’s premature to predict the long-term implications, considerable pricing pressure could significantly alter revenue opportunities across the approximated ten bHumira programs.

Teva’s Strategy Shift and Implications

On the Investor Day, Teva management seemed more focused on specific Near Term (NT) drivers such as Austedo, Uzedy, and the Innovative Pipeline, thereby overshadowing biosimilars. Key drugs such as Austedo, Ajovy, and Uzedy were highlighted as being vital for achieving the MSD growth target. Greater resources are being channeled to the Innovative side, particularly Austedo, for which a $2.5B revenue target has been set.

While biosimilars remain as a growth driver, Teva’s management appears to be repositioning towards innovative platforms. If Teva’s growth strategy is primarily centered on innovation, investors will anticipate the increased resource allocation to Austedo to yield higher volumes and a path to the $2.5B target. This, coupled with a successful Uzedy launch and sustained Ajovy growth (despite 2023 being a deceleration), will be essential.

Teva has clear ambitions for its pipeline, and though it could yield significant benefits in the long term, investor trust will hinge on tangible data. Key readouts (anti-TL1A Phase 2 in 2H24 and Olanzapine Phase 3 in 1H25) are still more than a year away. This delay, alongside the ambiguous future of the biosimilar market, may impact investor sentiment towards Teva.

Biosimilars U.S. Approval/Launch Timeline: Implications for the Humira Biosimilar Market

As competition in the Humira biosimilar market intensifies, the U.S. approval and launch of multiple biosimilars may reshape the sector’s dynamics. The following table details the existing and anticipated biosimilars for Humira:

Brand	Biosimilar	Active ingredient	Company	Approval Date	Actual/Expected Approval
Humira	Amjevita	adalimumab-atto	Amgen	23-Sep-16	31-Jan-23
Humira	Cyltezo	adalimumab-adbm	Boehringer Ingelheim	29-Aug-17	1-Jul-23
Humira	Hyrimoz	adalimumab-adaz	Sandoz	31-Oct-18	30-Sep-23
Humira	Abrilada	adalimumab-afzb	Pfizer	18-Nov-19	20-Nov-23
Humira	Hulio	adalimumab-fkjp	Viatris	9-Jul-20	31-Jul-23
Humira	Yusimry	adalimumab-aqvh	Coherus	20-Dec-21	1-Jul-23
Humira	Hadlima	adalimumab-bwwd	Organon/Samsung Bioepis	17-Aug-22	1-Jul-23

It’s clear that the Humira biosimilar market is moving toward a competitive phase with numerous players seeking or having gained approval. The addition of these biosimilars may help to foster a robust, competitive environment that could drive down prices and increase accessibility for patients.

The entry of new players like Organon/Samsung Bioepis and Coherus alongside established competitors like Amgen, Pfizer, and Boehringer Ingelheim indicates the breadth and depth of interest in the biosimilar market. The approval of these Humira biosimilars represents a key market opportunity given the high costs and substantial demand for this class of medication. This increased competition could be beneficial to patients and healthcare systems by providing more affordable and accessible alternatives to branded products.

However, the presence of multiple competitors also poses challenges, including potentially confusing pricing dynamics and the need for each manufacturer to differentiate their product in a crowded market. Manufacturers may need to invest in marketing and physician outreach to ensure their biosimilar uptake and negotiate with insurers and healthcare providers to secure formulary placement and patient accessibility.

In summary, the potential approval of AVT02 holds vast implications for the Humira biosimilar market, with a promising yet challenging future ahead. As Teva navigates its strategic shift towards innovative products, the biosimilar market will continue to evolve, underscoring the importance of continuous monitoring and competitive intelligence efforts.