Being First to File Isn't the Same as Being First to Launch: The Real Entyvio Race

Three vedolizumab biosimilar applications have been publicly announced as accepted for FDA review, from two developers. The order of those announcements is easy to read. Who can sell first is not. This piece sets out three different clocks, what each one shows as at 26 October 2026, and why the order of announcements is the weakest of the three.

Ask who is winning the race to launch a biosimilar of Entyvio (vedolizumab) and you will usually hear the order of the press releases. Alvotech announced first, on 8 June 2026. Polpharma Biologics announced on 31 July. Alvotech announced a second application on 31 August.

Here is what made me doubt that order. Takeda, which makes Entyvio, sued Polpharma Biologics S.A. on 26 August 2026 and sued Alvotech on 1 September 2026. The lawsuits came in the opposite order to the announcements.

That does not tell me who will sell first. Nobody can say that from the public record. It tells me that the order of press releases is one clock, and the race has more than one. This piece sets out three.

Three applications, two developers, one order of announcements

A biosimilar is a biologic medicine shown to be highly similar to an original one. Three biosimilar applications for vedolizumab have been publicly announced as accepted for FDA review. Alvotech holds two of them, AVT16 and AVT80. Polpharma Biologics S.A. holds one, PB016. Teva Pharmaceutical Industries Ltd. and Fresenius Kabi are named as commercialisation partners. They are partners, not applicants. The full status table is in the companion brief.

That count has a limit. Under 21 CFR 601.51(b), the FDA does not disclose that a biological product file exists before approval, "unless it has previously been publicly disclosed or acknowledged". So every count of who has applied is built from company announcements. A company that has applied and said nothing would not appear in it. I treat this as a count of announcements, not a count of every application that exists.

2 of 3 Two of the three announced applications are for the same intravenous (IV) product, a vial given as a drip. Only AVT80 is for a subcutaneous (SC) version, given under the skin from a prefilled syringe or an autoinjector. Source: Alvotech Forms 6-K, 8 June and 31 August 2026; Pearce IP, 31 July 2026

Exhibit 1. The three announced applications, and what has been said about each, as at 26 October 2026

Sources: Alvotech Forms 6-K furnished 8 June and 31 August 2026; Fresenius release and Pearce IP report of 31 July 2026; Takeda's complaints of 26 August and 1 September 2026 as published by Big Molecule Watch, and Goodwin's posts on them. The complaints are secondary sources here, because I have read them as published by Big Molecule Watch and not on the court dockets. The table lists what has been announced, which is not a complete list of what has been filed. Acceptance for review is not approval.

The word "first" needs care. Pearce IP (8 June 2026) and Goodwin's Big Molecule Watch (10 June 2026) both put "first" in their headlines for Alvotech's AVT16. Alvotech's own release of 8 June does not claim it. One Pearce IP post (31 July 2026) presents the "first to be accepted" wording as Alvotech's own announcement; the release I read has no such wording. I read "first" as "first announced", and that is how I use it below.

I used "first to file" in the title because that is how the market talks. The record does not let me use it as a fact. Pearce IP reports that the date Polpharma submitted its application is confidential, and the FDA will not supply it. So who submitted first is not public.

Clock one: who announced first

This is the clock people quote. It is also the one that tells you least.

An announcement date is not an acceptance date. Alvotech's release of 31 August 2026 puts the acceptance of AVT16 in May 2026. The announcement came on 8 June. For Polpharma Biologics I cannot see the acceptance date at all. Its announcement came on 31 July. Takeda's complaint says Polpharma gave notice of commercial marketing on 18 June, which is 43 days earlier. So the 31 July date tells me when the public heard. It does not tell me when the FDA accepted the application.

Clock two: the legal steps, where the order flips

US law gives a biosimilar maker and the maker of the original medicine a set of steps. They can swap information and lists of patents before anyone goes to court. People call this the patent dance. The maker of the biosimilar also gives a notice of commercial marketing, the notice the law requires at least 180 days before it first sells.

Here is what Takeda says in its complaints, as published by Big Molecule Watch and reported by law firms:

• Polpharma Biologics S.A. Takeda says Polpharma gave notice of commercial marketing on 18 June 2026, with marketing to start no earlier than 15 December 2026, which is 180 days later. The complaint also says Polpharma "declined to engage in the exchanges" that the law sets out for information and patent lists, which people call the patent dance.
• Alvotech. Takeda says counsel for Alvotech USA, Inc. wrote to it on 15 June 2026 that the FDA had accepted the AVT16 application. Takeda says access to the application was offered only if it signed a confidentiality agreement with terms wider than the law requires, and that it has not received the application or the manufacturing information.
• The lawsuits. Takeda sued Polpharma on 26 August and Alvotech on 1 September.

All of this is Takeda's account. I have read the complaints as published by Big Molecule Watch, not the court dockets, and I did not find either developer's reply.

Two things follow, and both are my reading.

The order of the lawsuits does not follow the order of the announcements. The record I read does not say why Takeda sued Polpharma first, and I will not guess.

A notice date is not a launch date. As at 14 October 2026 the FDA's records list no licensed biosimilar of vedolizumab. They do not list applications under review, so this says nothing about any application in progress. Takeda's complaint also says Polpharma's counsel told Takeda's counsel that approval is expected in May 2027, and that Polpharma believes it could come sooner.

That is a lawyer's remark as reported by Takeda, not an FDA date, and I do not rely on it. The 15 December 2026 date and the May 2027 remark are about five months apart. They show that a notice date and an approval date are different things.

Clock three: what each application can sell

An application asks the FDA to license a particular product. AVT16 and AVT80 are two products in two separate applications, according to Alvotech's release of 31 August 2026.

This matters because Takeda credits the subcutaneous form in its own commentary. In its Form 6-K of 30 July 2026, Takeda ties Entyvio growth in both the US and Europe to the subcutaneous formulation, alongside the effect of exchange rates. Takeda does not report IV and SC sales separately. So I cannot say how large the subcutaneous share is, and I will not estimate it.

Citeline's Generics Bulletin put the point in a headline on 31 July 2026: "Polpharma Matches Alvotech On Vedolizumab, But Trails On Subcutaneous Scope". I have read only the headline and standfirst, because the article body is behind a paywall. At that date Alvotech had no US subcutaneous application announced. That came on 31 August. Alvotech's release of 8 June 2026 says the European Medicines Agency had already validated a marketing application covering both AVT16 and AVT80.

In the sources I read, the US picture today is this. Alvotech has an IV and an SC application accepted for review. Polpharma Biologics has announced an IV application.

There is a second scope question, which is interchangeability. In the US, an interchangeable biosimilar can be substituted at the pharmacy without the prescriber stepping in, subject to state law. That is Alvotech's description. Alvotech has submitted AVT16 and AVT80 as proposed interchangeable biosimilars, and says regulators have not established interchangeability. I found no interchangeability statement for PB016.

The gate that is the same for everyone: six patents

Takeda's two complaints assert the same six US patents: 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969. Google Patents records one priority date, 2 May 2011, for all six, and an anticipated expiry of 2 May 2032, which it labels an assumption. I have not checked patent term adjustment or other term changes with the USPTO. Goodwin describes the six as method-of-treatment patents, including dosing regimens. Takeda's complaint against Alvotech gives US 9,663,579 the title "Formulation for anti-α4β7 Antibody", so the label is not settled. I have not read the patents' claims.

Whatever the order of the announcements, both developers face the same six patents. The complaint against Alvotech accuses AVT16 only. It mentions AVT80 as background, as I read it, so AVT80 is not an accused product. I did not search the Patent Trial and Appeal Board's own record, and a web search for the six numbers found no challenge there. That is a null result from a weak search, not proof that none exists.

London has a different set of parties. Five biosimilar companies are reported to have brought claims in London against Millennium Pharmaceuticals, which Pearce IP calls a Takeda subsidiary, to challenge European patents. Trial is listed for April 2027 for the first four (Pearce IP, JUVE Patent). Two of the five are tied to the applications above: Fresenius Kabi, the PB016 commercialisation partner, and Advanz Pharma, which Pearce IP calls the UK, EU and Swiss commercialisation partner for AVT16.

The other three, Accord Healthcare, Samsung Bioepis and Celltrion, have no US application that I found announced. A list built from the US announcements alone would miss them.

A precedent: approval and launch can sit years apart

Amgen said on 23 September 2016 that the FDA had approved Amjevita, which it called the first adalimumab biosimilar approved by the FDA (Humira is the reference product). On 31 January 2023 Amgen said Amjevita was now available in the United States. That is six years and four months between approval and availability. Neither release gives a reason for the gap, and I will not supply one. This is one example from another molecule. It proves nothing about vedolizumab. It shows only that an approval date and a launch date are two separate facts.

The part that is my argument, and the part that is sourced

What would change my mind

• A licence, with a date. If the FDA licenses a vedolizumab biosimilar, I want the licence date and the first sale date side by side. If the first announced application is also the first licensed and the first sold, with no legal step holding anyone back, order mattered more than I say. One case would not settle it.
• A court record that treats the developers differently. If a ruling shows the six patents bind one developer and not the other, the shared-gate point weakens.
• An FDA decision date from the FDA or from a company filing. A lawyer's remark in a complaint does not count.
• A subcutaneous application from Polpharma Biologics. That would change the scope picture in Exhibit 1.

Questions still open

If you are benchmarking a biosimilar race

• Ask which clock a statement is about. Submitted, accepted, announced, noticed, licensed and launched are six different events.
• Compare scope before order. List the presentations each application covers, and what each developer says about interchangeability.
• Read the shared gate. Where one set of patents is asserted against everyone, the order of announcements does not change it.

The FDA-record side of this is what LOE Edge reads. It does not read court dockets or patent term. How it reads those registers is on the methodology page. I make the same argument about presentations for another molecule in the pembrolizumab brief.

Who and what does this page refer to?

Several companies on this page act through more than one legal entity. The table gives each name as the source gives it, and the role that source gives it. Source numbers refer to the list at the end of the page.

Large companies operate through several legal entities, often one for each country or function. Press releases, court filings and regulatory records each name the entity that acted in that document, and these are not always the same one. This page uses the name each source gives. It does not treat two named entities as one company, or say that one controls the other, unless a source says so.

Where this page writes "Takeda" without naming an entity, it follows the source being cited: Takeda Pharmaceutical Company Limited in that company's filings, and the plaintiffs named in the complaints in the litigation sections.

Frequently asked questions

Related reading

• Vedolizumab biosimilars: US lawsuits and London claims: the status tables behind this piece.
• Pembrolizumab loss of exclusivity: the same question about presentations, on another molecule.
• How LOE Edge reads FDA registers: the method behind the FDA-record side of this.

Read the status table behind this piece

The companion brief sets out the three announced applications, the six patents and the London claims in tables, with every source named. LOE Edge reads US FDA records for a molecule: the Orange Book and openFDA for small molecules, and the Purple Book for biologics such as vedolizumab. It does not include court dockets or patent term.

Read the vedolizumab brief

Methodology and sources

Facts about the applications come from the developers' own releases, two of them furnished to the SEC, and from law-firm and trade reporting. Litigation details come from Takeda's complaints as published by Big Molecule Watch and from Goodwin and Pearce IP reports of them, and are secondary throughout, because I have not read the dockets. Patent dates come from Google Patents and are anticipated, not confirmed. No syndicated market research and no market size is used.

1. Alvotech, Form 6-K furnished 8 June 2026, on FDA acceptance of the AVT16 application: intravenous lyophilised vial, proposed interchangeable status, Teva Pharmaceutical Industries Ltd. as commercialisation partner, the European validation covering AVT16 and AVT80, and no claim to be first. SEC EDGAR.
2. Alvotech, Form 6-K furnished 31 August 2026, on acceptance of the AVT80 application: subcutaneous prefilled syringe and autoinjector, proposed interchangeable status, AVT16 acceptance in May 2026, and Teva Pharmaceutical Industries Ltd. as responsible for commercialisation with no territory stated. SEC EDGAR.
3. Fresenius SE & Co. KGaA, investor news of 31 July 2026 on behalf of Fresenius Kabi, on FDA and EMA acceptance of PB016, the intravenous scope, Polpharma Biologics S.A. as the submitting company, and the Fresenius Kabi commercialisation rights outside the Middle East and North Africa. fresenius.com.
4. Secondary. Pearce IP, 31 July 2026, on the PB016 acceptances: intravenous freeze-dried vial, no interchangeability statement, and Fresenius Kabi's rights. Pearce IP.
5. Secondary. Pearce IP, 8 June 2026, for its "first to be accepted" headline and its description of AVT16 as the first reported FDA application for a vedolizumab biosimilar. Pearce IP.
6. Secondary. Goodwin, Big Molecule Watch, 10 June 2026, for its "first to be accepted" headline. Goodwin.
7. Secondary. Citeline Generics Bulletin, 31 July 2026, headline and standfirst only; the article body is behind a paywall. Citeline.
8. Secondary. Goodwin, Big Molecule Watch, August 2026, on Takeda's complaint against Polpharma Biologics S.A.: the notice of commercial marketing of 18 June 2026, the six patents, the relief sought and the statement by Polpharma's counsel. Goodwin.
9. Secondary. Goodwin, Big Molecule Watch, September 2026, on Takeda's complaint against Alvotech: AVT16 only, the confidentiality-agreement allegation and the Teva Pharmaceuticals International GmbH allegation. Goodwin.
10. Secondary. Pearce IP, 26 August 2026, on the Polpharma complaint: the 15 December 2026 earliest date in the notice, the confidential submission date and the statement about approval in May 2027. Pearce IP.
11. Secondary. Takeda's complaint against Polpharma Biologics S.A., dated 26 August 2026, as published by Big Molecule Watch, for the parties, the notice of commercial marketing of 18 June 2026 and the 15 December 2026 earliest date, the statement that Polpharma declined to engage in the information exchanges, the statement by Polpharma's counsel, Fresenius Kabi USA, LLC as marketing partner and the six patents. Big Molecule Watch.
12. Secondary. Takeda's complaint against Alvotech hf, dated 1 September 2026, as published by Big Molecule Watch, for the parties, the letter of 15 June 2026 from counsel for Alvotech USA, Inc., the confidentiality-agreement allegation, the Teva allegations, AVT16 as the accused product and the six patents. Big Molecule Watch.
13. Takeda Pharmaceutical Company Limited, Form 6-K of 30 July 2026, for its commentary on Entyvio in the US and Europe and the subcutaneous formulation. SEC EDGAR.
14. Google Patents, US 9,663,579, for priority date and anticipated expiry. The other five patent numbers are given as text; Google labels anticipated expiry and legal status as assumptions. Google Patents.
15. FDA Purple Book, BLA 125476, read 14 October 2026, for the record of the original vedolizumab application. purplebooksearch.fda.gov.
16. FDA Drugs@FDA via the openFDA API, count by application number, retrieved 14 October 2026, for the list of vedolizumab applications and the absence of a licensed biosimilar. openFDA.
17. Secondary. Pearce IP, 31 July 2026, on the London proceedings: the four claimants, Millennium Pharmaceuticals as a Takeda subsidiary, Advanz Pharma as the UK, EU and Swiss commercialisation partner for AVT16, and the April 2027 trial listing. Pearce IP.
18. Secondary. JUVE Patent, 9 September 2026, for Celltrion as a fifth London claimant, the April 2027 listing of the other four proceedings, and Takeda as Millennium's parent company. JUVE Patent.
19. 21 CFR 601.51, for the rule that the FDA does not disclose the existence of a biologics file before approval unless it has previously been publicly disclosed or acknowledged. eCFR.
20. Amgen, press release of 23 September 2016, on FDA approval of Amjevita as the first adalimumab biosimilar approved by the FDA. Amgen.
21. Amgen, press release of 31 January 2023, on the US availability of Amjevita and its approval in 2016. Amgen.

Open items, stated rather than filled. The date Polpharma submitted its application is confidential, so who submitted first is not known. Takeda's account of the notice, the patent dance and the confidentiality agreement comes from its complaints as published by Big Molecule Watch, and I have not read the dockets or either developer's reply. Patent term adjustment, extensions and terminal disclaimers have not been checked with the USPTO, so every expiry here is anticipated.

The claims of the six patents have not been read. The Patent Trial and Appeal Board's own record was not searched. The FDA's records were last read on 14 October 2026. The body of the Citeline article was not read. Whether Takeda will add AVT80 to its complaint is not known. How the two Teva entities relate is not stated in the sources I read.

Nothing in this piece is investment advice or a recommendation about any security. Company names appear as the subject of cited public filings, announcements and litigation reporting. Allegations in a complaint are the pleading party's account and have not been tested. Nothing here predicts an outcome, a licensure date or a launch date. Acceptance for regulatory review is not approval.