Alvotech is forging an audacious path towards a potential game-changer. CEO Robert Wessman recently unveiled a resubmission of their Biologics License Application to the FDA, a strategic move aimed at securing an “interchangeability” designation for AVT02. This high-concentration biosimilar is Alvotech’s response to AbbVie’s formidable Humira (adalimumab).
This announcement, while sparking intrigue, leaves us in anticipation of an action date yet to be revealed. Alvotech’s focus, however, extends beyond paperwork and approvals. The biotech company is working diligently to ensure a “satisfactory inspection” of its manufacturing hub nestled in the picturesque landscapes of Reykjavik, Iceland. A critical step, as this facility holds the key to AVT02’s future.
Should the FDA grant its approval, AVT02 could very well become a “material contributor” to Alvotech’s business as early as 2024. This isn’t just about one product; it’s a strategic move with the potential to reshape Alvotech’s trajectory.
But this journey has not been without its hurdles. The FDA’s rejection of AVT02 has been a bitter pill to swallow, not once, but twice. The first setback struck in April 2023 when the regulator pointed to deficiencies at the Iceland facility in a resounding Complete Response Letter. In June, the FDA dashed Alvotech’s hopes for an interchangeability designation, marking yet another setback.
Enter Teva Pharmaceuticals, Alvotech’s trusted development partner. In July, their collaboration took on a broader dimension, with Teva increasing its involvement in manufacturing and quality control at the Reykjavik plant. It’s a strategic alignment aimed at addressing past issues and forging a path towards compliance and excellence.
The FDA’s scrutiny of Alvotech’s Reykjavik plant stems from a warning letter issued in March 2022, revealing worrisome quality control concerns. These included an “unacceptably high number of mold recoveries” from drug manufacturing rooms and documented bacterial contamination exceeding acceptable limits. The FDA found the company’s corrective and preventive measures wanting, deeming them “inadequate” in ensuring future contaminations would be avoided.
If AVT02 secures approval, it will enter a competitive arena, facing off against at least eight Humira biosimilars. The group is led by Amgen’s Amjevita, which marked its presence in the US market in January 2023. In July, the floodgates opened further with the launch of several other biosimilars, including Celltrion’s Yuflyma, Organon’s and Samsung Bioepis’ Hadlima, Sandoz’s Hyrimoz, and Boehringer Ingelheim’s Cyltezo.
“We continue to make significant investments in our manufacturing and quality processes and receiving US approval for AVT02, our interchangeable biosimilar candidate to high-concentration Humira, remains of highest priority. Meanwhile, we are expanding our global commercialization partnerships, based on extensive due diligence, which we believe demonstrates our partners’ trust in Alvotech and the strength of our platform approach to biosimilars development and manufacture. We are pleased with the recently concluded financing round which we believe also showed the capital markets’ confidence in our progress.”
– Robert Wessman, Chairman and CEO of Alvotech
Notably, only Cyltezo boasts the coveted interchangeability designation, allowing pharmacies to dispense it in lieu of the branded counterpart without the need for a prescription change.
On the financial front, Alvotech reported significant earnings, posting $22.7 million in the first half of 2023. This marked a substantial increase from the $3.9 million revenue recorded over the same period the previous year.
Alvotech’s odyssey is one of tenacity, determination, and unwavering commitment to elevating the standards of biopharmaceutical excellence. It’s a narrative that speaks to the industry’s resilience and the enduring pursuit of groundbreaking solutions, even in the face of formidable challenges. As we look ahead, Alvotech’s story unfolds as a testament to the ever-evolving landscape of biopharmaceutical innovation.