Pearce IP BioBlast w/e 03 May 2024

On 3 May 2024, Indian-headquartered Lupin, in partnership with Sandoz, announced its Canadian launch of etanercept biosimilar Rymti®, biosimilar to Amgen’s Enbrel®, with a full indication set.  Rymti® is supplied in a pre-filled pen and syringe and is Lupin’s first biosimilar launched in Canada.  Rymti® was approved in Canada in September 2022 following approval in Australia and Europe (where it is known as Nepexto®) in 2020.

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.  This follows news of its US sBLA submission on 11 March 2024 for guselkumab for the treatment of moderately to severely active ulcerative colitis.

Tremfya® (guselkumab) is approved in Europe for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically significant and clinically meaningful improvement, meeting its dual primary endpoint of overall survival.

In May 2021, the FDA approved Ketyruda® in combination with trastuzumab and chemotherapy for first line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.  The indication was approved under the FDA’s Accelerated Approval Program, which requires that studies are conducted to confirm the anticipated clinical benefit.  MSD reports that the final results from the KEYNOTE-811 trial will determine if Keytruda will receive continued FDA approval for the gastric cancer indication.

In February 2024, Keytruda® (with trastuzumab and chemotherapy) was approved in Canada for the same gastric cancer indication, based on earlier results of the KEYNOTE-811 study in relation to its dual primary endpoint of progression-free survival.

On 01 May 2024, Boehringer Ingelheim announced that the FDA approved its high-concentration, citrate-free formulation of Cyltezo® (biosimilar to Abbvie’s Humira® (adalimumab)), for multiple chronic inflammatory diseases.

BI now has approvals for the high (100 mg/mL) and low (50 mg/mL) concentration formulations of Cyltezo®, the latter on market since July 2023.  The newly approved high-concentration formulation of Cyltezo® is available in pre-filled syringes and autoinjectors.  Cyltezo® is priced 5% lower than Humira® and the unbranded biosimilar Adalimumab-adbm is offered at a price of 81% less than Humira®.

Alvotech and Teva’s Simlandi® received FDA approval on 24 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA.  FDA has also approved Samsung Bioepis’ Hadlima, Amgen’s Amjevita, Sandoz’s Hyrimoz, and Celltrion’s Yuflyma, as high concentration formulations.

On 30 April 2024, Alvotech announced a strategic partnership with Quallent Pharmaceuticals Health, under which a high-concentration interchangeable biosimilar to Humira^® manufactured by Alvotech will be distributed under Quallent’s private-label.  This partnership aligns with Alvotech’s existing U.S. commercialisation agreement with Teva.

Alvotech and Teva’s Simlandi® received FDA approval on 24 February 2024 as the first high-concentration, citrate-free biosimilar to Humira® to be granted interchangeable status by the FDA.

On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma.  This is the first US biosimilar approved for Accord BioPharma.

The approval relates to the 150mg dose product with the FDA decision on the 420mg dose expected in the fourth quarter of 2024.

Accord BioPharma has submitted BLAs for biosimilars of pegfilgrastim, filgrastim, and ustekinumab with launch of the latter licensed under a settlement with Janssen from 15 May 2025.

On 29 April 2024, each of Amgen and Sandoz announced that they resolved the US patent litigation regarding Sandoz’s denosumab biosimilars enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.

This concludes the District Court proceedings Amgen commenced against Sandoz in New Jersey on 1 May 2023alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva®.  The proceedings followed the FDA’s acceptance of Sandoz’s BLA for Jubbonti® and Wyost® in February 2023.

Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively.  No other denosumab biosimilars have received US approval to date.

In March 2024, the CHMP of the European Medicines Agency adopted a positive opinion for Sandoz’s denosumab biosimilars.  Jubbonti® was approved in Canada on 20 February 2024.  Other denosumab biosimilars have been approved in China: Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023), both biosimilars to Prolia®, and Mabwell’s Maiweijian^TM(denosumab 120mg) (April 2024), biosimilar to Xgeva®. Companies that have denosumab biosimilars under development include Samsung Bioepis,  Celltrion, Alvotech, Intas, and Shanghai Henlius Biotech.

Samsung Biologics revealed in its Q1 2024 Earnings that its subsidiary Samsung Bioepis has experienced year over year revenue growth of 31% and year over year operating profit of 6%, driven by sales expansion of its newly launched products.

Biosimilar highlights for Q1 2024 are reported to be the EC approval in April 2024 of Pyzchiva® (SB17, biosimilar to Janssen’s Stelara® (ustekinumab)); the Korean approvals of Epzystek^TM (SB17, ustekinumab) in April 2024, Afilivu® (SB15, biosimilar to Regeneron’s Eylea® (aflibercept)) in February 2024, and Episcli® (SB12, biosimilar to Alexion’s Soliris® (eculizumab)) in January 2024; the initiation of a global phase 1 clinical trial for SB27 (biosimilar to MSD’s Keytruda® (pembrolizumab)) in February 2024; and commencement of direct sales in Korea of SB2 (infliximab), SB4 (etanercept) and SB5 (adalimumab).