The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:
Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended 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 for this active substance.
Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®. Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration
To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.
During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.
BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for its tislelizumab product, co-developed with Novartis. It is seeking approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy.
In 2021, BeiGene and Novartis announced a collaboration agreement to jointly develop tislelizumab in the US, Canada, Mexico, member countries of the European Union, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Novartis is responsible for regulatory submission and has the right to commercialise in these licensed countries following regulatory approval.
On 10 July 2023, BeiGene and Novartis ended their option for collaboration and licence agreement to commercialise ociperlimab. Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.
Bristol Myers Squibb announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Opdivo® (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with completely resected stage IIB or IIC melanoma. If the European Commission approves this recommendation, Opdivo® will become the sole PD-1 inhibitor indicated as an adjuvant treatment for patients in stages IIB, IIC, III, as well as stage IV resected melanoma.
On 30 May 2023, the FDA accepted Priority Review for BMS’s NDA for repotrectinib for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer
Merck announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).
If approved, Keytruda® would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU.
Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test. Vanflyta® is the first and only FLT3 inhibitor approved by the FDA for FLT3-ITD positive AML for all three phases of treatment (induction, consolidation and maintenance) in patients without a transplant and newly diagnosed AML. Daiichi confirmed that Vanflyta® will be available in the US in the coming weeks.
On 12 July 2023, AstraZeneca and Daiichi’s Enhertu® (trastuzumab deruxtan) was approved for a new indication (unresectable or metastatic HER2-low breast cancer).
Sandoz announced that it will invest US$90M to build a Biosimilar Technical Development Centre in Ljubljana, Slovenia by 2026. The site will house an end-to-end drug substance and product development centre, becoming a ‘key location’ for Sandoz’s biosimilar product development.
This news comes only a few months after Sandoz signed an MOU to build a USD$400M biologics facility in Lendava, Slovenia in March 2023.
Novartis announced that its Board of Directors has unanimously endorsed the proposed separation of Sandoz from the Novartis Group, by way of a spin-off planned for Q4 of 2023. Shareholders at Novartis will have the opportunity to vote on the proposed spin-off and share capital reduction at an Extraordinary General Meeting on 15 September 2023. The spin-off aims to list Sandoz on the SIX Swiss Exchange, and completion is dependent on shareholder approval, meeting specific conditions, and obtaining necessary approvals for the listing of Sandoz shares.
This week on 20 July 2023, Sandoz announced it will build a US$90M Biosimilar Technical Development Centre in Slovenia, due for completion in 2026.
BeiGene announced that the FDA has completed a GMP inspection of its tislelizumab manufacturing facility. Tislelizumab is a PD-1 antibody and potential treatment for oesophageal squamous cell carcinoma (ESSC), and is being commercialised with Novartis. The Company confirmed that the BLA is moving forward, and it is seeking to gain approval in the EU to treat ESSC, and approval in China to treat hepatocellular carcinoma.
Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.
AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It was also approved to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season. The companies confirmed Beyfortus® will be available before the 2023/2024 RSV season. The FDA approval follows a unanimous vote on 8 June 2023 by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favourable benefit-risk profile of Beyfortus® based on the clinical development programme spanning three late-stage clinical trials.
A Hisun phase I study has demonstrated pharmacokinetic similarity and bioequivalence between HS628, a proposed tocilizumab biosimilar to Genentech’s Actemra®. The safety and immunogenicity profiles of HS628 were also found to be similar to the reference product in healthy Chinese male subjects. Actemra® is approved in the US for the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis patients. The study also notes that a phase III clinical trial is currently underway to compare the efficacy and safety of HS628 and Actemra® in patients with moderate to severe RA.
On 5 June 2023, Dr Reddy’s announced a successful phase I study of its biosimilar to Actemra®.
Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana. On 27 June 2023, Regeneron announced that that the FDA had issued a CRL in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.
The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.
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Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
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