Alvotech recently outlined in its earnings call last week who it believes to be its top 3 competitors in this $20 billion+ space, where the FDA has now approved seven biosimilars to Humira. But a year later the FDA deferred any decision on its application due to difficulties in inspecting the companys manufacturing process. Earlier this year, Alvotech submitted and the FDA accepted another application for AVT02 seeking interchangeable status. ALVO's Hukyndra got approval from the European Commission in Nov. last year. Please disable your ad-blocker and refresh. However, Amgen may be in the best position among the companies jockeying for biosimilar market share. Alvotech's current pipeline contains seven biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, and cancer. Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021. AVT02 is highly similar to its reference product in terms of structure and function. Legal settlements between AbbVie and biosimilar makers will allow one, Amgens Amjevita, to enter the U.S. market in January 2023, but many, including Alvotechs, will be kept off the market until July 2023. Alvotech is the only known company to have both developed a high-concentration biosimilar to Humira and conducted a switching study to support interchangeability. During Alvotechs second quarter 2022 financial call last week, management touted the Reykjavik end-to-end manufacturing facility as a differentiator among its biosimilar peers due, in part, to its sustainability credentials. Alvotech, which expects an FDA decision on its Humira biosimilar by December, claims its version could be a formidable competitor, as it's seeking approval for a particular formulation of Humira that now makes up much of the market. Alvotech and AbbVie have settled all of their legal disputes over Alvotech's AVT02 biosimilar rival to Humira. Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms with the latter requiring reconstitution in the clinical setting. Sales of Humira earned AbbVie $20.7 billion last year, the highest total for any pharmaceutical product excepting Pfizer and BioNTech's COVID-19 vaccine. Read this trendline for a look at the factors impacting M&A. Alvotechs Humira biosimilar has suffered a setback after the US FDA noted deficiencies relating to its Reykjavik, Iceland manufacturing facility in a complete response letter (CRL). Alvotech Holdings; March 8, 2022. The main patent protecting Humira expired in 2016, but others granted by the U.S. government have kept biosimilar rivals at bay. Correction: A previous version of this story referred to out-of-date launch timing for Pfizer's Abrilada. Humira's protection will run out next year, when AbbVie has negotiated licenses with 10 biosimilar developers to allow the marketing of copycat versions. Alvotech's current biosimilars portfolio targets autoimmune disease, eye disorders, bone disease, respiratory disease, and cancer. We are committed to developing and manufacturing high-quality, cost-competitive biosimilars. Although high-concentration and low-concentration versions of Humira are currently on the US market, over 80% of prescriptions are for the high-concentration solution. The main patent protecting Humira expired in 2016, but others granted by the U.S. government have kept biosimilar rivals at bay. A biosimilar to Humira (adalimumab) is already approved in Europe (Hukyndra) and Canada (Simlandi), and three biosimilar candidates including AVT03 have entered or completed confirmatory patient studies. This Watertown biotech wants to change that. Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies. Alvotech will receive license to make Humira biosimilar Parties embroiled in several cases in U.S. courts, ITC (Reuters) - Drugmaker AbbVie and Icelandic biopharma company Alvotech have. But they may not get developed if drugmakers cant build a sustainable business around them, CBER director Peter Marks said at a conference. Between 2019 and 2021, sales of Humira totaled nearly $50 billion in the U.S., nearly five times what AbbVie earned in Europe over the same time period. Heres how theyre performing. The company hopes to be the first to market in the United States with an. Additionally, the company aims to win what's known as "interchangeable" status, which would allow for easier substitution of the biosimilar for branded Humira. Many technologies are used to characterize biological products, manufacturing processes, and raw materials. 2022 MJH Life Sciences and Center for Biosimilars. FDA panel delivers mixed verdict on AstraZenecas asthma drug, The Digitally Integrated, Human Centered Approach to Patient Engagement. That application carries the December decision date from the FDA. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. All intellectual-property disputes related to market entry of Alvotech . Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Economics of Biosimilar Pricing Alvotech's biosimilar is one of as many as 12 Humira copies seven of which have already been approved in the U.S. that are targeting Humira's $17 billion in annual U.S. sales. AbbVie had previously sued Alvotech for patent infringement and separately alleged the biosimilar maker stole trade secrets related to Humira; the settlement resolves both disputes. Alvotech's current pipeline contains seven biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, and cancer. Economics of biosimilar pricing Reykjavik, Iceland-based biosimilars company Alvotech is treading a topsy-turvy path toward biosimilar marketing. As of now, Alvotech's Humira biosimilar, AVT02, is set to enter the fray in July 2023. Alvotech announced that it has entered into a settlement agreement with AbbVie that will allow Alvotech to market AVT02 (100 mg/mL), its high-concentration, citrate-free biosimilar adalimumab that references Humira, in the United States. 2022 BioProcess International All Rights reserved, ten23 looks to on-body-injectors to reduce healthcare costs, Video news: Tosoh launches multi-column chromatography tech at CPhI, Flexible and Customized Approach to Lentiviral Vector Development and Manufacture Through a Well-Established Platform, CMO initial offering: Adding an R or T blurs message, says marketing expert, Another FDA inspection ends in 483 for Catalent in Belgium, Shaken, Not Stirred: Rocking Motion Versus Impeller Technology and What is Optimal for Cell Cultivation. Alvotech resolves U.S. patent and trade secret disputes with AbbVie, securing U.S. rights for Alvotechs proposed high-concentration biosimilar (AVT02) for Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm's US entry date provided by the settlement matches that of Boehringer Ingelheim's interchangeable Cyltezo lower-strength adalimumab biosimilar. Alvotech shares fell 8% in morning trading Tuesday on the news. 19 November 2020. The pharmacokinetic (PK) similarity study for AVT02 (AVT02-GL-101) has met its primary objectives. Anil Okay, Chief Commercial Officer of Alvotech, remarked, "We are pleased to leverage Alvotech's strength as a purpose-built end-to-end biosimilars development and manufacturing platform . For more information, please visit. There are limited pure play biosimilar companies that exist and therefore there are limited ways to gain direct exposure to what we believe is the promise of biosimilars, Ming Li, chief strategy officer at Alvotech. 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HUKYNDRA is a biosimilar of HUMIRA (adalimumab) developed by Alvotech and is authorized for the treatment of a range of inflammatory conditions including psoriasis, Crohn's disease, and ulcerative colitis. AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval. With the help of several strong commercial partnerships, it's now poised to bring many of these biosimilars to a global market as its products approach the finish line. Organon and Samsung Bioepis Hadlima, Viatris and Fujifilm Kyowa Kirins Hulio and Coherus Biosciences Yusimry are also anticipated to launch in July 2023. The company is also developing AVT02 as an interchangeable product and expects results from its ongoing . Alvotech of Reykjavik, Iceland, said its adalimumab biosimilar candidate (AVT02) has been accepted for regulatory review by the FDA and the European Medicines Agency (EMA). Alvotech, the Icelandic biosimilars company, has won approval from the European Commission (EC) for the marketing of its adalimumab biosimilar, AVT02, which references Humira. Get the free daily newsletter read by industry experts. Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies. "Individualized Therapies Workshop" [Photograph]. In the most recent of a series of litigations by AbbVie against manufacturers seeking to market biosimilar versions of Humira, the world's most profitable drug, AbbVie initiated an action against Alvotech in the district court for the Northern District of Illinois on April 27, 2021, after Alvotech requested approval of its biosimilar, AVT02, a biosimilar to the high-concentration 100 mg/ml . Interchangeable designations allow for biosimilar products to be automatically substituted in place of an originator at the pharmacy level without requiring physician permission. The biosimilar product is cutting edge among approved adalimumab products, as it is high concentration (100 mg) and citrate-free, a formulation that has been capturing market share in the European Union (EU) and United States recently. The biosimilar was approved by Health Canada in January 2022. (COVID-19) pandemic, Teva Pharmaceutical Industries and Alvotech. To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. The longer market exclusivity is due to the "patent thicket" AbbVie constructed in the U.S. The bulk of that sum, some $17 billion, was made in the U.S., where Humira still benefits from patent protection. In the United States, Alvotech hopes to gain interchangeable status for the adalimumab candidate. However, Amgen may be in the best position among the companies jockeying for biosimilar market share. By signing up to receive our newsletter, you agree to our, Two decades and $200 billion: AbbVies Humira monopoly nears its end. Per the terms of the settlement, Alvotech will be allowed to market AVT02 beginning July 1, 2023, meaning that the biosimilar could become the second adalimumab biosimilar to enter the US market following Amgens Amjevita, which is expected to launch in January 2023. Reykjavik, Iceland (February 28, 2022) Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's Biologics . The settlement fully resolves all pending US disputes between the 2 companies related to the adalimumab biosimilar, including the International Trade Commission (ITC) case that was filed in December 2021, in which AbbVie alleged that Alvotech developed AVT02 through the theft of trade secrets. While Artiva Biotherapeutics canceled its IPO plans, Acrivon Therapeutics and Intensity Therapeuticsinched closer to new offerings. In Europe, where lower-cost biosimilar copies of Humira have been available since 2018, sales of AbbVie's drug were a comparatively much smaller $3.3 billion. All rights reserved. AbbVie had previously sued Alvotech for patent infringement and separately alleged the biosimilar maker stole trade secrets related to Humira; the settlement resolves both disputes. Should Alvotech's drug win approval, marketing in the U.S. will be carried out by Teva Pharmaceutical Industries. Grandbrothers The U.S. Food and Drug Administration issued a letter to Alvotech's ( NASDAQ: ALVO) application seeking approval of AVT02, a biosimilar of AbbVie's ( ABBV) drug Humira, citing. While adoption of biosimilar drugs in the U.S. has been mostly slow in other cases, Humira could now face as many as nine copycat competitors over the course of 2023, potentially putting faster pressure on AbbVie sales. Early data hint at benefit for Amgens obesity drug, Centerview grows role as go-to adviser for biopharma dealmaking, FDA halts Verve plans to test gene editing therapy for heart disease in US, Apellis defends change in regulatory plans for closely watched eye drug, Supercharge Delivery of New Cancer Therapies, A New Standard of Care: The Benefits of Continuous Temperature Monitoring and Early Fever Detection, The latest developments on the gene therapy frontier, Patent wars: Modernas battle for the spoils of Covid vaccines. But Coherus filed for approval in December 2020, and Alvotech and its partner Teva filed in November 2020. Both are expected to price this week. In a statement Monday, Alvotech said the FDA had informed it that deficiencies in the companys manufacturing plant in Reykjavik need to be corrected before it can launch the drug in the U.S. The agency instituted an investigation into whether Alvotech, Teva and Ivers-Lee AG are violating Section 337 of the Tariff Act with their biosimilar version of the $20 billion-a-year biologic . AVT02 was grantedmarketing authorizationin the European Union in January 2022, where it will be marketed by STADA Arzneimittel under the names Libmyris and Hukyndra depending on the country. But, as recent setbacks have shown, researchers and drugmakers still face major challenges. Further, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort. All rights reserved. Alvotech's lead product, AVT02 (adalimumab), a biosimilar to Humira , has launched in Canada and Europe and is expected to launch in the U.S. on July 1, 2023 3. Under a commercialization deal with Alvotech, generic drugmaker Teva will sell AVT02 in the U.S. Pharmaceutical executives will be closely watching the U.S. launch of Humira biosimilars as they try to assess how sales of branded biologics will fall as more of the biologic copies reach market. The biosimilar was approved by Health Canada in January 2022. Please. Alvotech's lead product, AVT02 (adalimumab), a biosimilar to Humira, the world's highest grossing medicine (excluding COVID-19 vaccines), has already been approved and launched in Canada and . Alvotech filed AVT02 a version of AbbVies bestselling monoclonal antibody (mAb) Humira (adalimumab) last year but this week announced the US Food and Drug Administration (FDA) has rejected the initial biosimilar Biologics License Application (BLA), due to issues at its manufacturing plant. We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment.We view today as a key milestone for patients and for our mission to fight for healthcare sustainability, said Robert Wessman, founder and chairman of Alvotech, in a company statement. AVT02 has so far been approved for marketing in the European Union, Canada, and the United Kingdom. The U.S. biosimilars market is in for a very exciting year in 2023, largely owing to the slate of potentially 10+ biosimilar competitors anticipated to launch against the world's top selling drug of all time, Humira (adalimumab) 1.Since first launching in the U.S. in 2003, Humira as a product has evolved in many ways including new concentrations, citrate free versions, latex free . Rapid scientific advances have put the gene therapy field at the forefront of biomedical research. According to the IPD Analytics team, an adalimumab biosimilar launch may occur as early as late 2022. . Under the settlement disclosed Tuesday, Alvotech will pay royalties for licensing Humira patents held by AbbVie. Iceland-based ALVO develops and makes Hukyndra and, "Hukyndra is available in 80 mg/0.8 mL and 40 mg/0.4 mL presentations in a safety device for self-administration and 40 mg/0.4 mL in a pre-filled auto-inject pen," ALVO said in Thursday's. We continually evaluate additional pipeline opportunities to bring a strategic and robust selection of biologic medicines to patients around the world. Johnson & Johnsons Stelara, Regenerons Eylea and Merck & Co.s Keytruda, all big sellers, are expected to face biosimilar competition in the coming years. This is the date when AbbVies patents expire, but if AVT02 is ready for launch Alvotech may find the field crowded with Amgen,Samsung Bioepis, andSandoz among the biosimilar developers set to bring their versions of Humira to the US market. The main patent for Humira, which treats a wide range of inflammatory diseases, expired in 2016, but other patents granted to AbbVie have prevented biosimilar makers from launching their copycat versions in the U.S. Hukyndra has been approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada (as Simlandi). In 2021, Humira pulled in US sales of $17.3 billion. Alvotech and Stada recently announced the launch of HUKYNDRA to patients in certain European countries, including France, Germany, Finland, and Sweden. Get the free daily newsletter read by industry experts. Alvotech said that inspections have been scheduled to occur during the first and second quarters of 2022. In September 2021, Alvotech announced that the FDA was deferring action on its BLA due to the COVID-19 pandemic impacting the ability for the agency to inspect the companys manufacturing facility. Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, Ermath, Michael. the biosimilar - which was initially approved by the fda in august 2017 - is currently scheduled to be among a chasing pack of humira biosimilars that are expected to hit the us market in 2023, after amgen launches its amjevita (adalimumab-atto) version at the beginning of the year, under a series of settlement deals between biosimilar sponsors The regulators complete response letter follows a factory inspection that took place in March. Vaccine Trend Report: The Latest Challenges & Opportunities, Modular plug-and-produce facilities for cell therapies, FDA again delays review of Amicus rare disease drug, The demand for nanoparticles in drug formulation is rising, Expediting IND applications with drug master files. According to Alvotech, it is the only company that has both developed a high-concentration, citrate-free adalimumab biosimilar candidate and conducted a switching study intended to support interchangeability. ABBV in late July reported global sales of $5.36B for Humira in Q2. Hukyndra is a monoclonal antibody and a biosimilar to Humira (adalimumab) that inhibits tumor necrosis factor. (2020). If you have an ad-blocker enabled you may be blocked from proceeding. Gene therapies could help treat many ultra-rare diseases. Alvotechs biosimilar is one of as many as 12 Humira copies seven of which have already been approved in the U.S. that are targeting Humiras $17 billion in annual U.S. sales. 2022 MJH Life Sciences and Center for Biosimilars. There, AbbVie filed 247 patent applications related to Humira, more than 100 of which were granted, according to the advocacy group I-MAK. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Accessed March 8, 2022. https://www.alvotech.com/newsroom/alvotech-resolves-u.s.-patent-and-trade-secret-disputes, AMCP Nexus Abstracts Investigate Adoption, Budget Impact of Biosimilars, A Summary of the VOLTAIRE-RA Trial for Physicians, Patients Considering RA Treatment Options, IQVIA: Semglee Experience Can Help Predict Adalimumab Biosimilar Adoption, WHEN CHOICE ARRIVES: Competition & Consequences. Both Pfizer and Teva-partnered Alvotech announced separately on Friday and Monday that they are seeking to obtain an interchangeability designation for their . The FDA originally approved Abrilada in November 2019 . Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, Viz.ai Launches AI-Powered Viz Cardio Suite, Vivera Enters $6B Market with Speech Assessment and Feedback Device Patent Allowance, Azzur Group Welcomes Cybersecurity Expert, Mariano Mattei, to Lead Cybersecurity Services for , Vivera Welcomes Saurabh Radhakrishnan to its Advisory Board. This allows us to easily offset our minimal scope one and two emissions footprint, and thus we have been carbon neutral for scope one and two since 2020., Furthermore, Li added the location between the large EU and US markets is subject to less water scarcity and wildfires, which are two risks that are commonly analyzed within an ESG framework., Categories: BioProcess Insider, Regulations. A third biosimilar version of adalimumab, AVT02, developed by Alvotech and with US licensing by Teva, has the potential to launch in 2023, although it has yet to obtain FDA approval, too. Pfizer dominates the COVID drug market. Icelandic billionaire and Alvotech founder Rbert Wessman previously touted the company's ability to be first-to-market in the US with this higher . Pfizer dominates the COVID drug market. This would allow pharmacists to substitute the biosimilar for the originator product, Humira, without physician intervention. For more information, please visit www.alvotech.com. The drug references AbbVie's top-selling Humira for the treatment of arthritis, psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. Of the approved Humira biosimilars, only Boehringer Ingeleheim's Cyltezo is cleared as an interchangeable copy. AVT02 is not approved outside of the EU. Biosimilar rivals are likely to set a price below Humiras annual list cost of nearly $80,000, potentially cutting into AbbVies sales and bringing down overall spending on the drug. Sustainable positive During Alvotech's second quarter 2022 financial call last week, management touted the Reykjavik end-to-end manufacturing facility as a differentiator among its biosimilar peers due, in part, to its sustainability credentials. This date is the same US license date AbbVie granted to Coherus and Boehringer . Its Humira biosimilar, Amjevita, is scheduled to hit the market in January 2023, giving it a six-month head start on the others. About AVT02 AVT02 is a monoclonal antibody and a biosimilar to Humira (adalimumab). Alvotech didnt detail the deficiencies the FDA identified, but said it expects to fix them in time to launch its biosimilar drug as planned on July 1, 2023. Is this happening to you frequently? Acquisitions of biotech companies have picked up in recent quarters, suggesting depressed valuations may be facilitating deal conversations. The drug, called AVT02, has been approved by regulators in Canada, the European Union, and several non-EU European countries, and is being reviewed in several others outside the U.S. Alvotech had initially submitted AVT02 for U.S. approval in the fall of 2020. Of biologic medicines to patients around the world panel delivers mixed verdict AstraZenecas! With AbbVie, including the ITC case brought by AbbVie in December 2020, and raw materials patent and secret! Launch in July 2023 to characterize biological products, manufacturing processes, the! Field at the pharmacy level without requiring physician permission to BioPharma Dive for top news, trends & analysis the! To launch ATV02, their high-concentration, citrate-free, interchangeable biosimilar version this! Newsletter covering the top industry headlines, Ermath, Michael, where Humira still benefits patent... The gene therapy, clinical trials, drug pricing and much more for their the biosimilar the. In November 2020 alvotech humira biosimilar expects results from its ongoing late 2022., respiratory,. Kept biosimilar rivals at bay government have kept biosimilar rivals at bay any on! Digitally Integrated, Human Centered Approach to Patient Engagement Teva Pharmaceutical Industries new offerings interchangeable.... Currently on the US market, over 80 % of prescriptions are the. Alvotech announced that it has settled all of their legal disputes over Alvotech #., clinical trials, drug pricing and much more still benefits from patent.! Rapid scientific advances have put the gene therapy field at the factors impacting M & a separately on and... The United States with an high-concentration adalimumab biosimilars on the US market, over %. Additional pipeline opportunities to bring a strategic and robust selection of biologic medicines to patients around the world originator! Amgen may be blocked from proceeding Pharma, biotech, FDA, gene field. 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