AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Patients will be eligible to receive Truqap® if they have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.
On 14 November 2023, AZ announced that China’s NMPA approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine and cisplatin).
Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies or biologics.
On 28 August 2023, AbbVie submitted applications to the EMA and FDA for Skyrizi® to treat moderately to severely active ulcerative colitis.
Merck announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
On 7 November 2023, the FDA revised the existing indication for Keytruda® for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ).
The French Parliament is debating 2024 budget reform (Social Security Financing Bill for 2024) which would enable pharmacists to substitute originator biologic products with biosimilars two years after the launch of the biosimilar. Under proposed amendments 1156, 2415 and 663, substitution could occur unless the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) objects. The proposed reforms align with the European Medicines Agency April 2023 opinion regarding the interchangeability of biosimilars.
Bristol Myers Squibb (BMS) announced the FDA approved its Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
On 30 October 2023, FDA approved BMS’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older.
The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab). Samsung appears to be ahead of several other companies in its pembrolizumab biosimilar clinical programme, noting that Samsung must commence its trial within a year of the approval. Formycon, Xbrane and Celltrion previously announced that they have pembrolizumab biosimilars in development. Formycon reported in its nine-month financial results for 2023 that its pembrolizumab clinical programme will commence in 2024. Xbrane reported in its financial reports for Jan-Jun 2023 that its pembrolizumab biosimilar candidate, Xtrudane™, is in preclinical development. Celltrion has not provided an update on the status of its development.
Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada. AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada. The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection.
This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)). The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.
Roche announced that the EU CHMP recommended the approval of its subcutaneous (SC) formulation of Tecentriq® (atezolizumab). The CHMP recommended Tecentriq SC for all indications for which Tecentriq® is approved, including various lung, liver, bladder and breast cancers.
On 27 October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® (faricimab) to treat macular oedema following retinal vein occlusion.
AstraZeneca announced that China’s National Medical Products Administration (NMPA) approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin).
On 22 February 2023, the European Commission approved Imfinzi® and tremelimumab immunotherapy combination to treat advanced liver and lung cancers.
Biocon Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), to treat neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. This follows the 20 September 2023 EC marketing approval Biocon secured for Yesafili®.
The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®. The company presented the final results of its 40 week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) 2023 conference in California.
Celltrion reported its 24 week results from the study in April 2023, the same month it reported that it submitted its application to the EMA.
CEO, Executive Lawyer, Patent & Trade Mark Attorney
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.
Underpinning Naomi's legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years' experience including as VP of IP in-house global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.
Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.