ALVO · Alvotech

The thesis

Alvotech's shares still turn on U.S. approval of two biosimilars made at its Reykjavik plant: AVT05, a copy of Simponi, and AVT06, a copy of Eylea. Press reports put the Food and Drug Administration (FDA) decisions on 4 December 2026. Approval of both confirms the case, and a manufacturing-related rejection breaks it.

The October releases made approval more likely. On 5 October 2026 the FDA approved a second Reykjavik production suite for U.S. supply of SIMLANDI, Alvotech's Humira biosimilar. Both 2025 rejections were tied to that plant, and a regulator unlikely to approve more U.S. output from a site it still considered a problem has now done so. On 6 October 2026 Alvotech signed a long-term manufacturing agreement with LOTTE Biologics in Syracuse, New York.

The narrative is still accelerating: the 5 October 2026 approval and the LOTTE release came on consecutive days, and the FDA decisions are less than two months away. Price has cooled since. The shares opened at $5.99 on 5 October 2026, against a $5.45 prior close, according to MarketBeat, and closed at $5.67 on 8 October 2026. The case is modestly better than even, because the decision date falls inside the next three months and the outcome stays binary.

Bullish and bearish views on Alvotech

The bull case on Alvotech (ALVO), in brief: The FDA cleared more Reykjavik capacity. The bear case: Product revenue has halved.

Bull case

• The FDA cleared more Reykjavik capacity. On 5 October 2026 the FDA approved a supplement to the SIMLANDI (AVT02) Biologics License Application that lets U.S. drug substance come from a second suite, DSM2, as well as DSM1. Alvotech said this doubles U.S. drug substance capacity for the product (GlobeNewswire).
• The plant inspection closed without enforcement. On 29 July 2026 Alvotech said the FDA had closed its 2026 Reykjavik inspection with a Voluntary Action Indicated classification. That rating carries no formal regulatory action.
• The decisions fall inside the quarter. Alvotech resubmitted both applications on 4 June 2026 and said the FDA had set goal dates in line with a standard six-month review, pointing to decisions in Q4 2026 (Form 6-K, Exhibit 99.2).
• Only manufacturing is in question. Both products are already approved in the European Economic Area, the UK and Japan, so the U.S. review does not depend on new clinical data.
• A U.S. supply source is coming. Under the 6 October 2026 agreement, LOTTE Biologics will make drug substance for several Alvotech antibody biosimilars at its Syracuse site, which has 40,000 liters of bioreactor capacity. The release said the site recently completed an unannounced FDA inspection with zero observations (GlobeNewswire).
• AVT06 has a U.S. launch window. A 19 December 2025 patent settlement allows U.S. marketing of AVT06 in Q4 2026, subject to FDA approval. Teva holds the U.S. commercial rights.
• Barclays turned positive. On 16 September 2026 Barclays upgraded the shares from Underweight to Overweight and raised its price target from $4 to $8.

Bear case

• Product revenue has halved. Product and service revenue was $105.9 million in H1 2026, against $204.7 million in H1 2025 (H1 results). The FY2026 guidance of $650–700 million, given on 19 August 2026, needs a much larger second half. Management said U.S. launch delays could lower it.
• Reykjavik has failed before. The FDA rejected AVT05 and AVT06 in November 2025 because of inspection findings at the same plant. Approval of a SIMLANDI supplement is a different decision from approval of two new products.
• Alvotech suspended its at-the-market program the same day (Form 424B5). The shares now trade well above that offering price, which makes another raise before the approvals bring in revenue a live possibility.
• U.S. sales depend on Teva. Teva holds U.S. rights to AVT05, AVT06, AVT16 and AVT80, so even after approval the speed of revenue depends on a partner's launch.

Price setup

The shares closed at $5.67 on 8 October 2026 in adjusted daily closes. That is 36.9% below the 52-week high of $8.98 and 67.8% above the price three months earlier. The 14-day relative strength index (RSI) is 46.1, a neutral reading that shows no stretched buying after the October gap.

The 5 October 2026 approval lifted the shares from a $5.45 close to a $5.99 open. By 8 October 2026 they had given back part of that move. The $3.75 June offering price is the main reference point below, and $4.40 sits between the offering price and the current close. A weekly close under $4.40 would undo most of the recovery since the offering.

There is no Form 4 crowding signal to read: Alvotech's insiders file no U.S. Form 4. The visible supply signal is the June 2026 issuance. The FDA decision date is the biggest pending event.

Catalysts, next 30 days

• No scheduled company event falls between 9 October 2026 and 8 November 2026. Unscheduled FDA actions on AVT03, AVT16 or AVT80, or further manufacturing releases, could still arrive.
• 11 November 2026 — Q3 2026 results, with the call on 12 November 2026. The results show whether the $650–700 million FY2026 revenue guidance holds before the FDA decisions.
• 4 December 2026 (date per press reporting) — FDA decisions on AVT05, AVT06 and AVT03. The case turns on these decisions. The company itself has said only Q4 2026 and its goal dates.
• ~31 December 2026, est. end of the Q4 2026 U.S. launch window for AVT06. A Teva launch after approval would start U.S. revenue for AVT06.

What would change the view

A manufacturing-related FDA rejection of AVT05 or AVT06 would break the case, because the November 2025 rejections came from the same plant. A delay past Q4 2026, or the quarter ending without both approvals, would also break it. A cut to the $650–700 million FY2026 revenue guidance at the 11 November 2026 results would weaken the recovery case without ending it. A new share offering before the decisions would also weaken it. On price, a weekly close below $4.40 would show that the market has stopped treating approval as the likelier outcome.

What it trades with

The shares trade mainly on FDA news about Alvotech's own products, so their link to the S&P 500 is loose around decision dates. Teva (TEVA) is the closest listed counterpart, since it sells AVT05 and AVT06 in the U.S. and depends on the same approvals. Swedish depositary receipts on Nasdaq Stockholm trade before the U.S. open and often move first on company releases. The shares are not tied to the AI, energy or rate-sensitive groups that drive most index moves.