BioBlast w/e 22 Sep 23

Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a non-binding MOU with Aurigene Pharmaceutical Services, a wholly-owned subsidiary of Dr Reddy’s Laboratories.  The Korea Economic Daily reported that Prestige Biologics will act as the primary manufacturing, packaging, and distribution hub in South Korea for Dr. Reddy’s extensive biopharmaceutical pipeline. Prestige plans to commence technology transfer next month in order to commence production immediately following execution of product-specific supply agreements.

On 12 July 2023, Dr Reddy’s announced that its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) will be reviewed by several global regulatory authorities, including the US FDA, EU EMA and UK MHRA.

Meitheal Pharmaceuticals announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars (insulin aspart, insulin lispro and insulin glargine) in the US. Under the agreement, Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical has the exclusive rights to commercialise the three biosimilars.  Meitheal anticipates regulatory approval of each of the biosimilars in around 2026.

On 1 April 2023, Eli Lilly launched its insulin glargine Rezvoglar®, biosimilar to Sanofi’s Lantus® in the US.

Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.  The first molecules will launch in 2025, while others are subject to further clinical development and registration. mAbxience will manufacture the biosimilars in Spain and Argentina, and will be responsible for achieving the clinical milestones for the molecules in development. Abbott will register and commercialise the biosimilars.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

This approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)  positive opinion for Yesafili® on 21 July 2023.

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024.  Alvotech stated that the FDA indicated that the resubmission, which incorporated additional Chemistry, Manufacturing, and Controls information, is considered to be a completed response to the FDA’s Complete Response Letter (CRL) of 28 June 2023.  Alvotech announced on 13 April 2023 that it had responded to an earlier CRL received in March 2023.

On 31 August 2023, Alvotech announced that it had resubmitted the BLA for AVT02 to the FDA but did not disclose details or the BsUFA goal date.

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.  The FDA has set a PDUFA date of 20 January 2024.

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 2021.  BeiGene now has complete global rights to Tevimbra® without having to pay royalties to Novartis and will supply Novartis with Tevimbra® for its clinical trials.  Beigene stated that Novartis will assist BeiGene to ensure the smooth development and commercialisation of Tevimbra®, including manufacture, regulatory, safety, and clinical facets.

On 21 July 2023, BeiGene received a positive CHMP opinion for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19.  Tyenne® is the first biosimilar to Actemra® / RoActemra® approved by the EC.

The CHMP issued a positive opinion recommending approval of Tyenne® on 21 July 2023.

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

On 5 June 2023, Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.

Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.  The agreement expands the existing 10-year manufacturing deal signed in 2013, as Samsung Biologics will manufacture the commercial antibody at its latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea.

Recently, in July 2023, Samsung Biologics entered into agreement with Pfizer  worth US$897M to manufacture biosimilar products for oncology, inflammation and immunotherapy until 2029 in Plant 4.  Samsung also confirmed on 6 June 2023 that it will open its fifth manufacturing plant in April 2025.

The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling.  The guidance includes proposed recommended approaches for:

• product identification, including when to use the biosimilar or interchangeable biosimilar product name, reference product name;
• content presentation; and
• specific sections of labeling, including prescribing information, indications, usage (including specific populations and paediatrics) and clinical pharmacology.

The draft document is open for comments by 17 November 2023.

KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five regions of Italy – accounting for approximately 20% of the Italian adalimumab market.  Yuflyma® recorded ₩54B (USD$40.7M) of sales in the first half of 2023, which Celltrion says is due to its expansion into Europe.

On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.