Authored and edited by attorneys in Rothwell Figgs Biologics and Biosimilars Group, Rothwell Figgs Biosimilars Law Bulletin provides updates, articles, and analyses regarding regulatory issues, legal decisions, and other news related to biologics and biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). The Board found first that Dixon expressly discloses that patients were treated on a p.r.n. Article Santen powers on . Interestingly, while the Board agreed with Regeneron that the claim preamble method for treating an angiogenic eye disorder in a patient was limiting, the Board was not persuaded by Regenerons arguments that the claims require a certain level of efficacy because the specification merely stated that [t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount and a therapeutically effective amount means detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEDF [sic] antagonist that inhibits, prevents, lessens, or delays the progression of an angiogenic eye disorder. See IPR2021-00881 at p. 20 (emphasis in original) (citing 338 Patent at 6:4850 and 6:5055). similar to last year, 2021 saw relatively few new biosimilar approvals from fda, with only four newly approved biosimilars: mylan's (now viatris's) semglee and eli lilly's rezvoglar , the. (citing 338 Patent at 3:3138). September 2019 alone has seen three darbepoetin alfa biosimilars approved in Japan. Dean Rudge Dean.Rudge@informa.com Executive Summary Viatris has reiterated the strength of its biosimilars and complex generics pipeline, highlighting opportunities including biosimilar Eylea, Botox and once-a-month Copaxone. We will keep monitoring these cases and report on future developments. Formycon. Regeneron also argued in connection with the 069 Patent that Dixon and another cited prior art reference, Heier 2009, failed to disclose the claim feature reciting wherein each tertiary dose is administered on an as needed/ pro re nata (PRN) basis, based on visual and/or anatomical outcomes as assessed by a physician or other qualified medical professional. However, the Board disagreed. Based on this timeline, FDA submission may not occur until the 2024 timeframe, which could make Coherus one of the late arrivals to market. Viatris president, Rajiv Malik, will have a seat on the board of this new company. In 2022, Viatris biosimilars portfolio is anticipated to generate $875 million in revenues and $200 million in profit. No. Novartis' blockbuster Gilenya exposed to generics in short term amid Supreme Court appeal. Earlier this month, Momenta was acquired by Johnson & Johnson, and M710 was the sole biosimilar remaining in its portfolio. Regeneron urged the Board to apply its discretion to deny institution as Dixon or other references that were before the Examiner and considered during prosecution constitute substantially the same art that was already considered by the Examiner. See IPR2021-00881 at pp. Viatris Biosimilars Evolution Viatris Biosimilars Experience R&D: 1st Interchangeable biosimilar approved by FDA in U.S., Semglee (insulin glargine-yfgn)* 1st Adalimumab biosimilar approved 9,669,069 are unpatentable, the Patent Trial and Appeal Board said. 11,053,280, 11,104,715, 11,174,283, and 11,186,625). Still, the company has notable international reach. Thus, the Board found that Mylan had established a reasonable likelihood in prevailing in showing unpatentability of at least one claim in each of the challenged patents. Article High-dose Eylea offers promise in wet AMD. In some ways, the deal they made more closely resembles a partnership buyout than an outright sale. We recently reported on Regeneron's battle with Novartis over a pre-filled glass syringe for injecting a VEGF-antagonist such as aflibercept into the eye.. Viatris reported $333 million in combined biosimilar and complex generics sales for the quarter just ended, down 5% from $351 in the comparable 2020 quarter; however, biosimilar sales were up 40%. The terms see Biocon hand over $2bn in cash and $1bn . Our biosimilars team is an integral member of our GLOBAL HEALTHCARE GATEWAY partnerships and helps make Viatris a true PARTNER OF CHOICE by extending our best-in-class in-house biosimilar expertise to your teams. In particular, the Board found that the disclosed press release failed to provide the additional disclosures relied upon by Mylan, including that VEGF Trap-Eye and aflibercept (the oncology product) have the same molecular structure, and therefore the same sequence. Eylea faces competition from an Eylea biosimilar from Viatris ( VTRS ) and . No. Specifically, within thirty (30) days after the reference product sponsor (RPS) has submitted a list of patents that could reasonably be asserted against the biosimilar manufacturer under 262(l)(3)(A), the RPS must provide the list of patents and their expiry dates to FDA. 10,464,992), and Reexamination 90/014,449 (challenging U.S. Pat. 2022 MJH Life Sciences and Managed Healthcare Executive. Regeneron Pharmaceuticals Inc. alleges a biosimilar version of Eylea proposed by a Viatris Inc. unit infringes 24 patents for the drug, used to treat retinal diseases and the source of more than a third of Regenerons 2021 revenue, according to a federal lawsuit in West Virginia. Bioeq began a phase 3 trial on July 23, 2020 to compare FYB203 to Eylea in 400 patients with neovascular, age-related macular degeneration. The Board found that based on the single page of Dixon, [i]t would consequently have been impossible for the Examiner to analyze the limitations of the challenged claims. IPR2021-00880 at pp. The biosimilars businesses owned by Viatris and Biocon have been intertwined for many years, and the partnership is heading for fuller consummation. 9,254,338); Reexamination 90/014,448 (challenging U.S. Pat. The Indian group is paying $3.3bn to take control of the partnership, allowing Viatris to pay down debt and focus on fewer, higher-margin areas. Both of Regenerons patents claim treating an angiogenic eye by sequentially administering to the patient a single initial dose of a VEGF antagonist, followed by one or more secondary doses of the VEGF antagonist, followed by one or more tertiary doses of the VEGF antagonist and further recite wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose. The 069 patent specifies that each tertiary dose is administered on an as-needed/pro re nata (PRN) basis, while the 338 Patent specifies that each tertiary dose is administered at least 8 weeks after the immediately preceding dose.. Analyst reaction was lukewarm considering the "disappointing" launch of insulin glargine in Europe more than two years ago. At least six other aflibercept biosimilars are in, or have completed, phase 3 clinical trials. See IPR2021-00880 at p. 31. According to Coherus, clinical trials for this biosimilar is slated to begin in 2021. According to Viatris executives, who spoke in an earnings conference call this week, in late 2023, an initial public offering will be held in India for a new biosimilars entity consisting of Biocon Biologics biosimilar operations and those that Viatris spun off. (Also see "Viatris Believes Eylea Biosimilar Candidate Is First To Reach US FDA's Desk" - Generics Bulletin, 10 Nov, 2021.) Can Biosimilar Development Costs Be Genericized? at p. 14. All Rights Reserved. No. Biocon is progressing trials for biosimilar rivals to Amgen's Prolia/Xgeva (denosumab) and J&J's Stelara (ustekinumab), even as it gears for other large opportunities coming its way via the Viatris deal including for blockbusters Humira and Eylea. Viatris' products from Pfizer include the erectile dysfunction aid Viagra (sildenafil) and cholesterol management drug Lipitor (atorvastatin); and from Mylan, Viatris gains the epinephrine auto-injector EpiPen. The completion date is December 2020. Viatris Humira biosimilar has significant revenue potential in the United States, but the launch will not occur before mid-2023, and that will be amid significant other competition from multiple biosimilars of Humira. Coherus BioSciences, the maker of the pegfilgrastim biosimilar Udenyca, is still in the preclinical development stage with its aflibercept biosimilar candidate CHS-2020. 10,857,231), IPR2022-00298 (challenging U.S. Pat. The $3.3 billion purchase by Biocon Biologics is more than 16.5 times the projected income figure. Enter your email address to subscribe to this blog and receive notifications of new posts by email. The Board credited expert testimony that the sequence of the VEGF antagonist which is marketed as aflibercept was disclosed well before January 2011 and that numerous references demonstrated that aflibercept, VEGF Trap (R1R2), and VEGF Trap-Eye, among other terms, were understood by a person of ordinary skill in the art to refer, interchangeably, to the same drug. IPR2021-00880 at p. 38 (quoting Mylans Declarants expert testimony). Cir. Regenerons recent Purple Book listing presumably comes as part of a Patent Dance with Viatris (formerly Mylan), which filed an aBLA for its aflibercept biosimilar MYL-1701P in late 2021. Article Teva and Bioeq partner on biosimilar eye drug. Celltrion Earns FDA Nod for Bevacizumab Biosimilar, The Inflation Reduction Act: Reducing Drug Prices and Maybe Future Biosimilar Development. The Board noted that Dixon expressly teaches that VEGF Trap-Eye and aflibercept (the oncology product) have the same molecular structure, but there are substantial differences between the preparation of the purified drug product and their formulations. There is a solution to this problem, check out https://evidentic.com/. With the loss, Eylea is expected to face competition from biosimilars, likely starting in 2024, according to Jefferies. Viatris Will Not Rule Out Symbicort In 2022 As Trial Looms The phase I trial for this aflibercept biosimilar was slated to begin October 2019 in patients with patients with neovascular age-related macular degeneration. This site uses Akismet to reduce spam. The newly combined business entity, Viatris, has joined the original 9 members of the Washington, DC-based Biosimilars Forum. The overall sales decline in this combined category was attributed to generic drug competition. However, reviewing the prosecution of the 069 patent (IPR2021-00880), the Board found that only a single page of the Dixon reference was filed in an information disclosure statement (IDS). For its part, Viatris markets biosimilars of Humira (adalimumab) and Enbrel (etanercept) outside the U.S. and is working toward gaining an approval for a biosimilar of Eylea (aflibercept) approval. Regeneron reported Q4 2019 US revenues for the innovator product Eylea at $1.22 billion, which represented a 14% increase over the same quarter of 2018. 10-13. Although it will receive a substantial amount of money in the Biocon Biologics transaction, Viatris is not getting out of the biosimilars business completely. Id. 9-11; see also IPR2021-00880 at pp. We do not sell or distribute actual drugs. 10,464,992, terminated due to settlement), PGR2021-00035 (challenging U.S. Pat. Biosimilars can fill an urgent, unmet patient need for more affordable alternatives to existing branded biologic therapies. Mylan cited several references in each of its petitions as being anticipatory references, but the respective parties arguments and the Boards focus centered substantially on the Dixon reference. In the Patent Owners Preliminary Response to each petition, Regeneron argued that Dixon fails to disclose the amino acid sequences required by the challenged claims. With a primary completion date of August 2021, this should enable Formycon to file an application with the EMA in 2025 and/or the FDA sometime in 2022 and potential US introduction in 2023. Learn how your comment data is processed. A Regeneron Pharmaceuticals Inc. dosing patent used in the retinal-desease drug Eylea, the source of more than a third of its 2021 revenue, was canceled Wednesday.. Given the growth of the biosimilars market and the revenues that some companies are reporting, it was a shock to the investment community this week when Viatris, formed in 2020 from the merger of Mylan and Pfizers Upjohn unit, announced plans to sell its biosimilars unit to Biocon Biologics. Viatris will receive consideration of up to USD 3.335 billion, including cash up to USD 2.335 billion and Compulsorily Convertible Preference Shares (CCPS) in BBL, valued at USD 1 billion. Declaratory Judgment Jurisdiction Over Skinny Label Applications: Coherus Scores First Interchangeable Biosimilar Approval for Lucentis, Senators Urge Regulators to Block and Clear Patent Thickets. Five Things To Look Out For In September Article Theramex and Enzene join forces on Prolia biosimilar. Can Biosimilars Fund New Specialty Pipeline Development? Oct 14, 2022 09:49am. Several aflibercept biosimilar candidates are in development, hoping to market after the 2020 US patent expiration. The Board did, however, acknowledge an apparent discrepancy concerning the molecular weight of aflibercept and VEGF Trap-Eye in the prior art, but did not find this discrepancy to be sufficient to deny institution given the identical structures. Regeneron Pharmaceuticals Inc.alleges a biosimilar version of Eylea proposed by a Viatris Inc.unit infringes 24 patents for the drug, used to treat retinal diseases and the source of more than a third of Regeneron's 2021 revenue, according to a federal lawsuit in West Virginia. Eylea has significantly greater sales (and growing) than Lucentis. To learn more about our firm and other practice areas, visitwww.rothwellfigg.com. Dixon was relied upon both as an anticipatory reference and as a primary reference for the obviousness grounds in each petition in combination with (IPR2021-00881), or optionally in combination with (IPR2021-00880), Regenerons earlier publications (Papadopolous and Dix references). At least six other aflibercept biosimilars are in, or have completed, phase 3 clinical trials. 2022 Bloomberg Industry Group, Inc. All Rights Reserved. Regeneron and partner Sanofi Genzyme own the rights to Zaltrap. The U.S. Patent and Trademark Office (USPTO) recently instituted two of Mylans petitions seeking Inter Partes Review of Regenerons U.S. Patent No. This is the latest development in a series of battles over Eylea, which has been marketed in the United States since 2011, has enjoyed $8.36 billion in revenues in 2020, and is the third highest grossing biologic product in the world as reported here. We work to address unmet needs through science and innovation to bring important medicines to market, such as our pending once-monthly glatiramer acetate, a generic Symbicort , a biosimilar to Avastin , a biosimilar to Eylea and biosimilar to Botox , and serve patients at every stage of life. In March 2022, Viatris announced that Biocon Biologics would take over Viatris' entire biosimilar business. Instead, the Board found that the specification clearly indicated that the terms initial dose, secondary doses, and tertiary doses, merely refer to the temporal sequence of administration of the VEGF antagonist. Also, Viatris will retain a 12.9% stake in the new enterprise, and that stake will be nondilutive, meaning presumably that Viatris will retain its almost 13% share if Biocon Biologics issues more stock or brings in more investors. The asserted claims of Patent No. Regeneron reported Q4 2019 US revenues for the innovator product Eylea at $1.22 billion, which represented a 14% increase over the same quarter of 2018. 18-05-2021. No. Proportionally speaking, Biocon Biologics is much more committed to biosimilars. PITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway. These include SB-15 (Samsung Bioepis), ABP 938 (Amgen), FYB203 (Formycon and Bioeq), SOK583A19 (Sandoz), CT-P42 (Celltrion), and OT-702 (Ocumension Theraputics and Shandong Boan Biological Technology). The Patent Trial and Appeal Board (the Board) instituted both petitions on all grounds asserted by Mylan. We recently reported on Regenerons battle with Novartis over a pre-filled glass syringe for injecting a VEGF-antagonist such as aflibercept into the eye. Over a pre-filled glass syringe for injecting a VEGF-antagonist such as aflibercept into the eye Nod for Bevacizumab biosimilar the! 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