BioBlast w/e 24 Nov 23

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the positive results from Celltrion’s Ph III trials of CT-P42 which were reported on 3 April 2023.

Express Pharma reported that Enzene Biosciences has launched its biosimilar ranibizumab in India (biosimilar to Genentech’s Lucentis®) for the treatment of neovascular age-related macular degeneration (AMD).  This is Enzene’s seventh Indian biosimilar.

On 7 September 2023, we reported that Enzene would ‘imminently’ launch its biosimilar ranibizumab.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

Chugai Pharmaceutical announced the Japanese launch of Phesgo®, a subcutaneous combination of pertuzumab and trastuzumab (Genentech’s Perjeta® and Herceptin® respectively) to treat HER2-positive breast cancer and advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.

The Japanese National Health Insurance (NHI) reimbursement price list included Phesgo® on the day Chugai launched it. Phesgo® was approved by the Ministry of Health, Labour and Welfare on 25 September 2023.

Sandoz has launched its high concentration formulation (100mg/ml) of Hyrimoz® in Europe, biosimilar to AbbVie’s Humira® (adalimumab).  This citrate-free high concentration formulation is indicated for all conditions for which Humira® is supplied.

Hyrimoz® was granted marketing authorisation in the EU on 3 April 2023.  The same formulation was approved by the FDA on 21 March 2023.

BeiGene and Ensem Therapeutics announced that BeiGene will acquire Ensem’s investigational new drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor as part of an exclusive global licensing deal.  Ensem will receive an upfront payment and is eligible for additional payments upon achievement of development, regulatory, and commercial milestones, totalling up to US$1.33B. Ensem will also receive tiered royalties.

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties.

AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of treatment patents.  The alleged infringements arise from the respondents’ respective submissions of Abbreviated Biologic License Applications (aBLA) to the FDA seeking approval of their Rinvoq® biosimilars.

AbbVie is seeking injunctions preventing the supply of the upadacitinib biosimilars, and damages.  AbbVie has also sought orders that the effective date of any FDA approval of the respondents’ ANDAs be no earlier than the last expiry date of the allegedly infringed patents (with the earliest expiring patent on 9 June 2029, and the latest expiry is 9 March 2038) or any later exclusivity expiry.

On 18 May 2023, the FDA approved an expanded indication for Rinvoq® to include adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers.

Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Switzerland.  Sam Chun Dang will receive up to €20M from the unnamed distributor, with the agreement implementing a 50% profit share arrangement.

On 24 August 2023, Sam Chun Dang licenced SCD411 to Apotex for Canada.

Almirall announced that its received marketing authorisation from the European Commission (EC) for Ebglyss® (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Almirall will first launch Ebglyss® in Germany and continue distribution in other European countries in 2024.  Almirall licensed the rights to develop and commercialise lebrikizumab in Europe for dermatology indications from Dermira in June 2019, which was acquired by Eli Lilly in January 2020.  Eli Lilly has exclusive rights for Ebglyss’® development and commercialisation in all other jurisdictions outside of Europe.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Ebglyss® to treat moderate and severe forms of atopic dermatitis in adults and adolescents.

Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey.  The alleged infringement arises from Dr Reddy’s submission of its Abbreviated Biologic License Application (aBLA) to the FDA seeking approval for DRL_RI, its Rituxan® biosimilar.  The originators allege that Fresenius assisted Dr Reddy’s in its aBLA application.

On 12 July 2023, Dr Reddy’s announced its BLA for DRL_RI was accepted for review by the FDA following acceptance of its DRL_RI dossier by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) filed in April 2023.

EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers.  On 30 April 2019, Sandoz and EirGenix inked a deal under which EirGenix develops & makes Herwenda®, and Sandoz commercialises the biosimilar on approval for all regions other than Taiwan, China, Russia, and some Asian countries.

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Herwenda®.