On 16 and 17 May 2024, respectively, the Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety approved MSD’s Keytruda® (pembrolizumab) for the following additional indications:
- locally advanced cervical cancer; and
- as an adjuvant after surgery for early-stage non-small cell lung cancer (NSCLC) in patients who have undergone resection and platinum-based chemotherapy.
The new cervical cancer approval is based on the KEYNOTE-A18 study and comes after MSD received Korean approval for Keytruda in April 2024 for patients with FIGO 2014 stage III-IVA cervical cancer in combination with chemotherapy.
The new NSCLC indication is based on the KEYNOTE-091 study and increases to six the number of on-label NSCLC indications for Keytruda in Korea.
As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®, were valid and infringed by Mylan and Biocon. On 17 May 2024, Judge Kleeh granted a temporary restraining order, prohibiting Mylan/Biocon from manufacturing, using, marketing and selling their Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron. The restraining order operates for 14 days, unless otherwise extended.
Regeneron’s proceedings against Mylan and Biocon are one of six US actions brought by Regeneron regarding aflibercept biosimilars, with the other actions involving Amgen, Celltrion, Samsung Bioepis (2 actions) and Formycon. All proceedings are centralised in the Northern District of West Virginia and are ongoing. A hearing scheduled for 2 May 2024 regarding a motion by Regeneron for a permanent injunction again Mylan/Biocon and motions for preliminary injunctions against Celltrion, Formycon and Samsung Bioepis, was cancelled by order dated 26 April 2024. A scheduling conference was held on 17 May 2024, the transcript for which is not yet publicly accessible.
On 15 May 2024, Formycon announced its partnership with MS Pharma in MENA for the commercialisation of its aflibercept biosimilar FYB203. Klinge Pharma GmbH, which holds the global commercialisation rights for Formycon’s FYB203, granted MS Pharma exclusive rights to license, commercialise, and produce FYB203 in Saudi Arabia for the Middle East and North Africa (MENA).
MS Pharma markets Formycon’s Ravegza® (FYB201, ranibizumab) in the MENA region.
In June 2023, the FDA accepted Formycon’s BLA for FYB203 and its MAA application was accepted by EMA in December 2023.
During the first case management of this case in the Federal Court of Australia on 14 May 2024, it became clear that Cipla is challenging the patent term extension (PTE) on Novo Nordisk’s liraglutide formulation patent (AU 2004290862). The 9-month PTE was granted on 4 August 2011 and is due to expire on 26 August 2025. If Cipla succeeds in its challenge, the expiry date will become 18 November 2024.
According to submissions made in open Court, pending timely and favourable resolution of its challenge, Cipla plans to launch liraglutide biosimilar on 19 November 2024.
A three-day substantive hearing has been scheduled for the end of October 2024.
This follows the Indian launch of a liraglutide biosimilar, Glenmark’s Lirafit® in January this year and the approval in the UK of Biocon’s liraglutide biosimilar in March 2024.
On 13 May 2024, Regeneron and Sanofi announced that the FDA has accepted for priority review their supplemental biologics licence application (sBLA) for Dupixent® for adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP). The target action date for the FDA decision is 15 September 2024. If the new indication is approved, it will be the first treatment in the US for adolescents with inadequately controlled CRSwNP.
This is the second sBLA for Dupixent® accepted for priority review this year, with an sBLA for a 6th indication of uncontrolled COPD in adults accepted in February 2024.
On 13 May 2024, Outlook Therapeutics announced that it submitted a Marketing Authorisation Application (MAA) in the UK for its ophthalmic formulation of bevacizumab (ONS-5010, LYTENAVA™) for the treatment of wet AMD. Outlook Therapeutics is seeking to achieve FDA, EU and MHRA approval for the launch of bevacizumab as the first approved ophthalmic formulation of bevacizumab, which has been used off label for ophthalmic conditions for many years. Outlook Therapeutics suggests that approval may also be sought in Japan, other EU markets, and elsewhere.
The UK submission follows the positive opinion for LYTENAVA™ issued by the EU’s Committee for Medicinal Products (CHMP) on 22 March 2024. The International Recognition Procedure allows MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from the European Union, Australia, Canada, Japan, Switzerland, Singapore and/or the United States.
On 13 May 2024, Boehringer Ingelheim (BI) announced a partnership with Cigna subsidiary Quallent Pharmaceuticals, under which Quallent will distribute high and low-concentration forms of BI’s citrate-free adalimumab biosimilar in the USA under its private label. BI will continue to market its adalimumab products.
BI’s high concentration Cyltezo® was approved by the FDA in May 2024 and a low concentration formulation has been on the US-market since July 2023.
BI is the second Humira® biosimilar manufacturer to partner with Quallent, with Alvotech announcing last month its US partnership with Quallent to supply Alvotech’s high-concentration interchangeable adalimumab biosimilar.
On 13 May 2024, Novo Holdings A/S announced the acquisition of a 60% majority stake in growing Austrian life sciences tools company Single Use Support. The two co-founders of Single Use Support will each retain a 10% stake, and Danaher Corporation will hold the remaining 20%.
Founded in 2017 in Austria, Single Use Support develops equipment and consumables for bioprocessing, focusing on biological drug substances, cell and gene therapies, and mRNA vaccines.
This news follows the 25 March 2024 announcement by Novo Nordisk of its acquisition of Cardior Pharmaceuticals for (up to) € 1.025B.
On 13 May 2024, Novo Nordisk announced positive results from the FRONTIER 2 trial, a 26-week phase 3a study evaluating the efficacy and safety of once-weekly and once-monthly subcutaneous administration of Mim8 for the treatment for haemophilia A. The study demonstrated that Mim8, a FVIIIa bispecific antibody, significantly reduced treated bleeding episodes across both treatment groups and was found to be safe and well-tolerated.
Novo Nordisk plans to seek regulatory approval for Mim8 by late 2024 and will present additional data in upcoming conferences and publications.
This news follows the 10 April 2024 announcement of Novo Nordisk’s partnership with Ginkgo Bioworks.
On 6 May 2024, by order unsealed on 10 May 2024, the United States District Court for the District of Delaware refused to grant Alexion injunctive relief against Samsung Bioepis for alleged infringement of claims of two Alexion patents relating to methods for treating paroxysmal nocturnal hemoglobinuria (PNH) (US 10590189) and atypical haemolytic uremic syndrome (aHUS) (US 9447176) with eculizumab. The patents are due to expire on 8 September 2027 and 22 August 2032, respectively.
The PI application was part of the BPCIA litigation commenced by Alexion on 3 January 2024 alleging infringement of 6 patents relating to Samsung Bioepis’ aBLA for SB12, its biosimilar to Alexion’s Soliris® (eculizumab). The litigation is ongoing.
Alexion also filed proceedings on 19 March 2024 against Samsung Bioepis (and Amgen) in the Hamburg Local Division of the UPC seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).
SB12 was launched as Epysqli® in Germany, Italy and Spain in 2023 and in Korea in April 2024.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.
Faran Shahzad
Foreign Qualified Lawyer (NZ)
Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assisting with office actions.
With a background in physiology, Faran is passionate about life sciences industries. His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.