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BioBlast w/e 23 Oct 23

by , | Oct 24, 2023

Celltrion announced that the FDA has approved its subcutaneous formulation of Zymfentra® (infliximab -dyyb), biosimilar to Janssen’s Remicade®, as maintenance treatment for ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an IV infliximab.  This is the first FDA approved subcutaneous formulation of infliximab.  Zymfentra® is marketed as Remsima SC® in Europe.

On 2 October 2023, Celltrion announced that the FDA approved Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosage forms.

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.  This will simplify the procedure for prescribers for obtaining authority to prescribe (ie an authority script) for certain biosimilar medicines which are reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS).   The affected medicines are:

The intention of these changes is to encourage greater use of biosimilars by easing the administrative burden for prescribers to obtain the necessary authority. For initial therapy with a biosimilar, authority from Services Australia may be obtained by telephone or online with immediate effect, rather than in writing. The requirement to obtain prior authority to prescribe the biosimilar for continuing therapy will be removed, with the requirement now ‘Authority Required (Streamlined)’.

For the rheumatoid arthritis medicines, in general brand substitution of a biosimilar with the reference brand will not be permitted where the approval was by telephone, online or by Streamlined prescription. An exception applies for subsequent continuing therapy where substitution is permitted by the prescriber.

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approval, but did not identify any issues with safety or manufacturing.  The companies confirmed that the ongoing clinical trial is enrolling patients, and results are expected in late 2024.  According to Regeneron and Sanofi, these trials should provide the additional efficacy data required by the FDA.

On 11 July 2023 Sanofi received MA for Dupixent® in India to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.

The FDA has issued Samsung Biologics with a Form 483 containing six key observations following site inspections on 21-25, 28-31 August and 1 September 2023.  A Form 483 is issued to companies at the conclusion of an FDA inspection if conditions may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.  A Form 483 does not constitute a final FDA determination of violation of the FD&C Act or any relevant regulations.  Fierce Pharma has reported that Samsung is taking the FDA’s concerns seriously and has “developed a comprehensive plan” to address the manufacturing shortfalls swiftly.

The Korea Herald reported that Samsung Bioepis has launched Epysqli®, its biosimilar to AstraZeneca/Alexion’s Soliris® (eculizumab) in three European countries.  Samsung Bioepis confirmed it is preparing to launch Epysqli® in France and the Netherlands by the end of 2023.

Samsung Bioepis’ Epysqli® was approved by the EMA on 30 May 2023.

Merck and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and commercialise the candidates around the world, except for Japan, where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply.

Merck will pay Daiichi a US$4B upfront payment and US$1.5B in continuation payments over the next 24 months. Contingent on Daiichi meeting future milestones, Merck may make additional payments of up to US$16.5B, reaching a total potential consideration of up to US$22B.

On 18 October 2023, the EC approved AstraZeneca/Daiichi’s (trastuzumab deruxtecan) for a new indication as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer.

AstraZeneca and Daiichi Sankyo announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The EMA’s CHMP recommended the indication extension for Enhertu® on 15 September 2023.

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD).  Soliris® is the first and only complement inhibitor approved for the treatment of NMOSD in China.

On 24 August 2023 Soliris® was approved in Japan for a new indication to treat paediatric patients with generalised myasthenia gravis.

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/originator outcomes found that Biogen’s Benepali® and Novartis’ Erelzi® demonstrated comparable efficacy to Enbrel®.   Erelzi® was the first etanercept biosimilar approved by the FDA on 30 August 2016, with  Samsung Bioepis’ Eticovo® (marketed as Benepali® in Europe) receiving FDA approval on 25 April 2019.

On 17 October 2023, AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib) to for new indication: moderate to severely active Crohn’s disease.  This follows the recent Canadian approval (9 May 2023), of Rinvoq® for the treatment of Active Non-Radiographic Axial Spondyloarthritis.

The FDA approved Rinvoq® for moderate to severely active Crohn’s disease on 18 May 2023.

Korea Biomed has reported that US pharmacy provider CarePartners Pharmacy will exclusively supply Celltrion’s biosimilar adalimumab (Yuflyma®) in the US.  It has removed AbbVie’s Humira® from its product line.  The partnership will be relevant to the supply of adalimumab to more than 10 million patients linked with CarePartners.

On 5 October 2023, Celltrion USA announced that Ventegra® listed Yuflyma® as a “preferred drug” from early October 2023.

Merck made two announcements regarding new indications approved for Keytruda® (pembrolizumab):

  • In the US the FDA granted approval for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. This brings the total number of NSCLC-related indications for Keytruda® in the US to six.
  • In Europe the European Commission (EC) granted approval for Keytruda® as a monotherapy for the adjuvant treatment of adults with SCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Naomi Pearce

Naomi Pearce

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 Hope

Sian Hope


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.

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