Alvotech (NASDAQ:ALVO) executives said the biosimilar developer is entering a key commercial and regulatory period after resubmitting multiple U.S. biologics license applications and receiving acceptance of a filing tied to its proposed biosimilar to Entyvio.
Speaking at a Goldman Sachs healthcare event, Founder and Executive Chairman Róbert Wessman said Alvotech has invested nearly $2 billion in research and development and manufacturing since its founding in 2013. He described the company as a “pure-play biosimilars” business with end-to-end R&D and manufacturing capabilities in-house.
FDA resubmissions follow facility-related CRL
Wessman said Alvotech recently resubmitted three BLAs in the U.S., including applications for biosimilars to Simponi and Eylea. He said prior complete response letters did not include comments on the BLAs themselves, but instead focused on the company’s facility.
“There were no comments on the BLAs themselves, but there were some comments on the facility,” Wessman said. He said Alvotech spent roughly 10 months addressing the issues and implemented more than 200 corrective and preventive actions.
Wessman outlined three areas cited by the FDA: the use of pharmaceutical-grade silicone lubrication with rubber stoppers in syringes, processes for following up on complaints tied to auto-injectors, and general environmental monitoring observations that he said were below action limits. He said the company was ultimately able to operate the relevant equipment without lubrication and submitted three months of data without environmental monitoring “hits.”
Balaji Prasad, Alvotech’s chief strategy officer, said the timing of the resubmissions was notable because investors had been watching whether a recent FDA inspection would delay filings. He said the company viewed the inspection outcome as manageable and that filing in the first week of June was a positive signal.
Wessman said Alvotech believes the FDA may not need another inspection, but added that the company is prepared if the agency returns. He said the review timeline is expected to be six months, which would point to early December and potentially allow launches before year-end.
Entyvio biosimilar filing seen as major opportunity
Alvotech also discussed what executives described as a significant milestone for its proposed biosimilar to Entyvio. Prasad said acceptance of the submission was “one of our most important near term to medium term opportunities,” citing a global market size of about $7.5 billion and a sizable U.S. market.
Wessman said Alvotech believes only one other developer is close to its position and said the company is not aware of another submitted product. He also highlighted Alvotech’s subcutaneous version of the product, calling the opportunity “by far the biggest” in the company’s short commercial history.
For Simponi, Wessman said Alvotech is already seeing strong uptake in Europe, with market share reaching up to 40% in some markets. He said the company believes it could still be first to market or in the first wave in the U.S. Prasad added that the commercial opportunities for Simponi and Eylea remain intact because many relevant market settlements are tied to late 2026 or early 2027.
Pipeline focus includes high-dose Eylea and Keytruda
Wessman said Alvotech is also pursuing a high-dose biosimilar to Eylea, noting that the company began internal work before the branded high-dose product launched. He said Alvotech has seen about 40% conversion to the high-dose product in both Europe and the U.S. and expects to submit in rest-of-world markets this year, while U.S. clinical work continues.
On Keytruda, Wessman said Alvotech wanted the world’s largest molecule in its pipeline despite expected competition. He said the company is co-developing the product with Dr. Reddy’s and expects the development cost to be lower because it anticipated being able to avoid a patient study.
Manufacturing partnership and market outlook
Wessman said Alvotech’s partnership with FUJIFILM is intended to add flexibility and establish additional manufacturing capacity for commercial and pipeline products. While Alvotech’s Iceland facility has capacity beyond 2030, he said the timing of expected launches and market-share gains made a second source strategically valuable.
Asked about broader biosimilar market dynamics, Wessman said biologics represent about 40% of the $1.8 trillion pharmaceutical market and could rise to 50% or 60% over time. He said the industry still has high barriers to entry, including development costs of $60 million to $90 million per product and the need for major manufacturing investment.
Prasad said changes such as waivers of certain comparative efficacy studies could benefit companies with strong analytical and process capabilities, because regulators may increase scrutiny of the submitted data.
Wessman also discussed 2026 guidance, saying the lower end of the company’s range did not include contribution from three U.S. products expected to launch in December. He said the company had included only a moderate assumed shipment value at the high end because of the limited time remaining in the year.
Looking ahead, Wessman said Alvotech’s product selection strategy centers on being first or in the first wave of biosimilar launches. Prasad said six of the company’s next eight to nine expected launches over the near to medium term could be first-to-market or first-wave opportunities, citing Ilaris, Cimzia and Taltz among future assets expected to contribute revenue and EBITDA.
About Alvotech (NASDAQ:ALVO)
Alvotech (NASDAQ:ALVO) is a global biopharmaceutical company specializing in the development, manufacturing and commercialization of biosimilar medicines. The company focuses on creating high‐quality, cost‐effective alternatives to established biologic therapies in areas such as immunology, oncology and other specialty care fields. By leveraging in‐house research and a vertically integrated manufacturing platform, Alvotech aims to bring approved biosimilars to market more rapidly and with greater cost efficiency than many traditional biosimilar developers.
Since its founding in 2013, Alvotech has built a diversified pipeline of monoclonal antibody biosimilars, targeting blockbuster reference products including adalimumab (originally branded Humira), bevacizumab (Avastin) and ustekinumab (Stelara).
