Pearce IP BioBlast w/e 29 March 2024

On 28 March 2024, the Korea IT Times reported the US launch of Celltrion’s pediatric 20mg Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of pediatric autoimmune disease. Three Yuflyma® dosage forms are now available in the US, with an 80mg dose launched in January 2024 and a 40mg dose, first approved by the FDA in May 2023, launched last year.  All dosage forms are the high concentration formulation of adalimumab (100mg/mL).

Earlier this year, Celltrion applied to the FDA seeking interchangeable status for Yuflyma®.  Celltrion has previously said that it “tentatively expects” interchangeability designation to be granted in Q4 2024.

Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).  If approved, enfortumab vedotin with Keytruda® (pembrolizumab) would become the first combination treatment to offer an alternative to platinum-containing chemotherapy in China.

The European Medicines Agency (EMA) validated a Type II variation application for the same indication earlier this year.

On 27 March 2024, Korea Biomedical Review reported that Korean biologics manufacturer Rophibio (affiliate of  healthcare company Amicogen) entered into an agreement with US biotech Avantor to supply raw materials and provide support for the development of a biosimilar to MSD’s Keytruda® (pembrolizumab).   Amicogen has reportedly completed the cell line development, and process development with Avantor.  Reportedly, Rophibio will determine market entry dates based on patent barriers and the competitive landscape.

The Korea Biomedical Review reports that South Korean company, Sam Chun Dang Pharm Co Ltd (SCD), has entered an exclusive distribution agreement with an unnamed distributor to supply its Eylea® (aflibercept) biosimilar in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland.  SCD attributes the deal to it being the first to apply for European Medicines Agency approval for an aflibercept biosimilar pre-filled syringe.

SCD’s biosimilar to Regeneron’s Eylea®, SCD411, was also the subject of an exclusive distribution agreement reported in November 2023, between SCD and an unnamed distributor, for supply to Austria, Germany, Italy, Spain and Switzerland.  In North America, SCD has licensed SCD411 to Apotex for the Canadian market.

On 25 Mar 2024, Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for (up to) € 1.025B comprised of an initial payment and milestone payments.

Cardior Pharmaceuticals specialises in RNA-targeted therapies aimed at preventing, repairing, and reversing heart diseases.  Its lead compound, CDR132L, reportedly selectively blocks abnormal levels of miR-132.  Phase 1b trial results showed promising safety and tolerability along with promising cardiac functional improvements in heart failure patients.  As reported in Novo Nordisk’s press release, the ongoing phase 2 trials aim to benefit individuals with heart failure with reduced ejection fraction (HFrEF) who have previously experienced a heart attack.

The Novo Nordisk press release states that it plans to initiate a second phase 2 trial to investigate CDR132L in a chronic heart failure population with cardiac hypertrophy.

The acquisition is expected to be finalised in the second quarter of 2024, subject to regulatory approvals.

This news follows the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it acquired global contract development and manufacturing company Catalent for USD $16.5B, a deal which is expected to close in late 2024.

On 24 March 2024, the Korea Economic Daily (KED) reported Samsung Bioepis entered pre-clinical stage, with multiple undisclosed gene therapy candidates, for the treatment of rare diseases.

According to KED, Samsung Bioepis is committed to advancing drug development through the utilization of antibody-drug conjugates (ADCs), and by next year it intends to submit an investigational new drug (IND) application to initiate a phase 1 clinical trial, with a focus on rare diseases such as liver and metabolic disorders.

The Biden Administration proposes to amend s352 of  the Public Health Service Act so that all approved biosimilars are deemed to be interchangeable with their respective reference drug.

On 11 March 2024, the Biden Administration released its 2025 Budget Proposal in which it recommends allowing biosimilar substitution without FDA’s determination of interchangeability.  According to U.S. Department of Health & Human Services (HHS):

“The statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding, including among patients and healthcare providers, about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars”