Biosimilars
Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission
In October 2023, Iceland-based biosimilar manufacturer Alvotech, announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara (ustekinumab). As such, the application was not approved. This follows Alvotech’s September 2023 resubmission of a BLA for their high-concentration biosimilar formulation to AbbVie’s blockbuster arthritis treatment Humira (adalimumab), AVT02 [1], following receipt of a similar CRL.
Japanese approval for first ustekinumab biosimilar
Iceland-based biosimilar manufacturer Alvotech announced on 25 September 2023 that its commercialization partner in Japan, Fuji Pharma Co Ltd (Fuji) had received marketing approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its ustekinumab biosimilar AVT04 in Japan.
ASCO policy statement on biosimilars and interchangeables in oncology updated
The American Society of Clinical Oncology (ASCO) has released a new policy statement on the use of biosimilar and interchangeable products in oncology.
The statement proposes guidance and recommendations for stakeholders, including manufacturers, payers, regulatory agencies, clinicians, and patients, to ensure equitable access to high-quality care and to address challenges to biosimilar uptake [1].
Biosimilar anti-VEGF: transforming retina treatment economics in South Asia
Anti-vascular endothelial growth factors (anti-VEGF) agents combat retinal diseases causing blindness. However, high costs and non-adherence pose challenges. Ophthalmic anti-VEGF ranibizumab biosimilars, which have received multiple approvals in South Asia, are helping to reduce healthcare costs and revolutionize ophthalmic treatments.
Long-term data support the clinical comparability of AVT04 to Stelara
Long-term efficacy, safety and tolerability data for the AVT04 ustekinumab biosimilar candidate developed in partnership by Alvotech and STADA corroborate the finding of therapeutic equivalence to the Stelara® reference product in patients with moderate-to-severe chronic plaque psoriasis (PsO) in the primary endpoint at Week 12.
FDA approves first tocilizumab biosimilar Tofidence
On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.
Promotion of biosimilar product development in Puerto Rico
The Puerto Rico Economic Development Bank (Banco de Desarrollo Económico para Puerto Rico, BDE)announced in August 2023 a funding of US$3.85 million for Biosimilar Sciences PR, LLC (Biosimilar Sciences) and Ocyon Bio PR Inc (OcyonBio) to facilitate the purchase of specialized biotechnology equipment. This funding comes from the State Small Business Credit Initiative (SSBCI) of the US Treasury for Small Businesses.
FDA grants interchangeable designation to adalimumab biosimilar Abrilada
US-based pharma giant Pfizer announced on 5 October 2023 that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Topline results for Hadlima biosimilar in interchangeability study
Samsung Bioepis and Organon announced topline results from interchangeability study of their Humira biosimilar, SB5/Hadlima, in August 2023.
EMA recommends approval of trastuzumab biosimilar Herwenda
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2023 that it had recommended granting of marketing authorization for the trastuzumab biosimilar Herwenda, 150 mg, for intravenous use.
