Alvotech (NASDAQ:ALVO) Chief Strategy Officer Balaji Prasad said the biosimilar developer is preparing to resubmit three biologics license applications to the U.S. Food and Drug Administration in June after addressing manufacturing observations that led to complete response letters for pipeline products.
Speaking with BofA Securities pharma and biotech analyst Jason Gerberry at the BofA Annual Healthcare Conference, Prasad said the company has been commercial in the U.S. market since the launch of its biosimilar Humira in 2024 and followed with the launch of its biosimilar Stelara in February 2025. He said Alvotech generated “just about” $600 million in revenue last year and about $140 million in EBITDA. For the current year, the company has guided to $650 million to $700 million in revenue and $180 million to $200 million in EBITDA.
Prasad described Alvotech’s pipeline as one of the largest in the biosimilar industry, citing 32 assets, including five that are commercial. He said the company’s next wave of launches is expected to include several limited-competition opportunities, which he described as a key differentiator.
FDA Resubmission Planned After Manufacturing Observations
Prasad said the FDA inspected Alvotech’s Reykjavik facility in late June and early July of last year as part of a pre-approval inspection and issued a Form 483 with 10 observations. He said the agency later narrowed the outstanding issues to three observations, which he identified as involving the use of silicone lubricant, complaint-handling processes and microbial contamination.
The inspection affected pending approvals for biosimilar versions of SIMPONI, EYLEA and Prolia, Prasad said. He emphasized that the agency’s concerns were tied to facility observations rather than the products themselves and said the company has continued shipping its biosimilar Humira and Stelara to the U.S. “every single month” without issue.
Prasad said Alvotech has compiled about six months of data to demonstrate that process improvements are sustainable. He also said the company made a “painful” decision to slow production to implement broader process improvements, which affected recent quarterly results.
Alvotech expects to resubmit the three BLAs in June, which Prasad said would begin a six-month approval clock and could support approvals by December. He also noted that the FDA recently conducted a surprise inspection at the Reykjavik facility, which concluded with “a few observations” that the company believes are manageable. Prasad said Alvotech is preparing for the possibility of another FDA inspection but has not been told whether one will be required.
SIMPONI Seen as Most Time-Sensitive Pipeline Opportunity
Among the three products affected by the complete response letters, Prasad said SIMPONI is the product the company is most excited about, followed by EYLEA and then Prolia. He said Prolia was always expected to be a competitive market, while SIMPONI remains a potentially attractive commercial opportunity with limited competition.
Prasad said Alvotech hopes to be among the first to market for SIMPONI and has a strong commercial partner in Teva. He added that the opportunity remains intact even though another potential competitor has a PDUFA date in May.
For EYLEA, Prasad said the timing impact is more limited because Alvotech’s settlement allows for a launch in the fourth quarter. He said the company expects approval in the fourth quarter, assuming the resubmission process proceeds as planned.
Fujifilm Deal Expands Manufacturing Network
Prasad also discussed Alvotech’s recently announced agreement with FUJIFILM Diosynth Biotechnologies to expand its global manufacturing network and establish a second source of commercial supply in the U.S. and the U.K.
He said the rationale was twofold: ensuring capacity beyond 2030 and reducing dependence on the Reykjavik site. Alvotech has previously said its Reykjavik facility can meet global demand through 2030, but Prasad said the company wants to prepare for future pipeline needs and establish a U.S. manufacturing base.
Prasad said Alvotech is currently involved in technology transfer to the Fujifilm site for currently commercial products. He said the process is expected to take about 12 months, with manufacturing and U.S. sales from the facility expected in the second half of next year. He said decisions on single-source versus dual-source supply will be made product by product, based on competitive dynamics and commercial importance.
ENTYVIO, EYLEA HD and Other Pipeline Assets Highlighted
Prasad said Alvotech recently submitted a marketing authorization application in Europe for a biosimilar to ENTYVIO and expects to file in the U.S. this year, with potential approval next year. He described ENTYVIO as one of the company’s most attractive upcoming opportunities and said Alvotech expects limited competition and a potential one- to two-year competitive advantage period.
He also highlighted a high-dose EYLEA biosimilar program, saying Alvotech has started confirmatory trials and believes it is ahead of many competitors. Other near- to medium-term pipeline opportunities discussed included XOLAIR in Europe, CIMZIA and Taltz. Prasad said Alvotech has also disclosed KEYTRUDA as an asset, though he characterized that market as likely to be competitive.
Commercial Dynamics and Biosimilar Market Outlook
On current U.S. products, Prasad said Alvotech’s Humira biosimilar has the second-largest share among biosimilars, with more than 10% of the biosimilar market. For Stelara, he said the company is de-emphasizing the private-label channel while Teva is gaining formulary traction and Alvotech is winning downstream contracts.
Prasad said private label is likely to be less important for the next wave of biosimilar launches, which he characterized as more focused on buy-and-bill products than pharmacy-dispensed products such as Humira and Stelara.
Asked about FDA efforts to lower development barriers for biosimilars, Prasad said reduced clinical trial requirements could lower development costs, compress timelines from roughly six to seven years to five to six years, and allow Alvotech to pursue more programs. He said the increased emphasis on analytical data plays to one of the company’s strengths.
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).
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