BioBlast w/e 2 Jun 23

01 JUN 2023 | EU | New indication alert: EC approves Novartis’ Cosentyx® (secukinumab) for HS

Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe hidradenitis suppurativa (HS) in adult patients who have had an inadequate response to conventional systemic HS therapy.  This is the first biologic treatment approved for HS in nearly a decade.  Novartis said a decision from the FDA for this indication is expected later this year.

This approval follows the CHMP recommendation last month.

01 JUN 2023 | US | Coherus 85% discount for US launch of YUSIMRY® (biosimilar adalimumab) & partnership with Mark Cuban

Coherus announced it is launching YUSIMRY® (adalimumab-aqvh) biosimilar to AbbVie’s Humira®, in July 2023 with a list price of $995 per carton.  This is the lowest price announced of any adalimumab product in the US, and represents an 85% discount on the originator product.

On the same day, Coherus also announced a partnership with Mark Cuban Cost Plus Drug Company (MCCPDC) to offer MCCPDC customers YUSIMRY® in July 2023 for $569.27 plus dispensing and shipping fees.

YUSIMRY® was approved by the FDA in December 2021 indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.  As the AbbVie global Humira® (adalimumab) empire crumbles, Samsung Bioepis/Merck has the next licensed launch date in the US on 30 June this year, and the next day (1 July) the following biosimilar entities are licensed launch: Alvotech, Celltrion, Boehringer Ingelheim, Coherus before Fresenius Kabi in July (on an unspecified date), Mylan/Viatris on 31 July 2023, Sandoz on 30 September 2023, Momenta and Pfizer on 20 November 2023.

31 MAY 2023 | Celltrion phase I data for biosimilar to Genentech’s Actemra® (tocilizumab)

Celltrion has released its clinical phase I data for its tocilizumab product CT-P47, biosimilar to Roche’s Actemra® which it announced at the 2023 European Congress of Rheumatology (2023 EULAR).  Celltrion has successfully demonstrated pharmacodynamic equivalence and safety comparable to Actemra®.

Last week Celltrion filed a MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab).

30 MAY 2023 | IN | Lupin & Enzene (Alkem) collaborate on biosimilar to Eli Lilly and Merck’s Erbitux® (cetuximab)

Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’s biological arm) to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’s Erbitux®.  Cetuximab is approved by Drug Controller General of India for treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN).

In February 2023, Enzene Biosciences began supply of its Humira® (adalimumab) biosimilar in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.

30 MAY 2023 | EU | Approval alert: EC grants MA for Samsung Bioepis’ Epysqli® biosimilar to Alexion’s Soliris® (eculizumab)

The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli® is approved for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH), and is Samsung Bioepis’ first hematology biosimilar.

The EMA Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Epysqli® on 30 March 2023.

26 MAY 2023 | US | Alnylam sues Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines

Alnylam commenced  proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer alleging patent infringement over Alnylam’s RNA Lipid Particle Technology encompassed in United States Patent Nos. 11,590,229, 11,633,479, 11,633,480 and 11,612,657.  Alnylam claims that its patented technology is ‘foundational to the success of the recently-developed messenger RNA (mRNA) based COVID vaccines’.

Alnylam alleges that Moderna:

• infringes Alnylam’s ’479 patent and ’480 patent by using SM102, a protonatable biodegradable lipid formulated into lipid particles that protect and deliver the vaccine’s mRNA;  
• infringes Alnylam’s ’229 patent by using Alnylam’s patented lipid particles that protect and deliver Moderna’s COVID-19 Vaccine’s mRNA (comprising four lipids: SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3- phosphocholine [DSPC]); and 
• used confidential information presented to it in discussions between Alnylam and Moderna in 2013/2014 about a potential license Alnylam’s IP along with a potential business relationship or a collaboration. 

Alnylam alleges that Pfizer infringes: 

• Alnylam’s ’479 patent through the use of ALC-0315, a lipid compound used in Pfizer’s COVID-19 Vaccine; 
• the ’480 patent through the use of ALC-0315, which is formulated into a lipid particle that protects and delivers the vaccine’s mRNA; and 
• Alnylam’s ’657 and ’229 patents through the use of Alnylam’s patented lipid particles that protect and deliver Pfizer’s COVID-19 Vaccine’s mRNA (comprising four lipids: ALC-0315 (a protonatable biodegradable lipid), 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide (a PEG-modified lipid), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol).  

Alnylam is seeking to recovery monetary compensation for Moderna and Pfizer’s unlicensed use of Alnylam’s patents.  Alnylam is not seeking injunctive relief.

26 MAY 2023 | UK | MHRA announces new regulatory recognition routes with seven international partners

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory recognition routes for medicines, utilising approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US to expedite new product approvals. This framework will leverage the expertise and decision-making of regulatory partners to expedite the assessment of specific products, resulting in faster access to medicines in the UK and reducing costs and streamlining regulatory processes for the industry. The UK regulator will remain responsible for approving and/or rejecting applications under the new framework. The MHRA expects the framework will be in place by Q1 2024.