BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s ustekinumab, denosumab

by , | Oct 24, 2022

Significant biosimilar activities this week include:

21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™

Spectrum Pharmaceuticals announced the US launch of Rolvedon™ (eflapegrastim-xnst), a market which is estimated to be valued at over US$2B.  Rolvedon was FDA approved in September 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

21 Oct 22 | US | Eylea® granted six months paediatric exclusivity

Regeneron announced that the FDA has granted paediatric exclusivity for Eylea® (aflibercept), extending market exclusivity in the US to 17 May 2024. Paediatric exclusivity was granted on the basis of Ph III trials of Eylea as a treatment for retinopathy of prematurity in preterm infants.

20 Oct 22 | CA | Saskatchewan adopts biosimilar switching program for 6th province/territory

The Saskatchewan Ministry of Health announced the introduction of a biosimilar switching program – the 6th of its kind to be introduced into provinces/territories in Canada. Under the new program, the Saskatchewan Drug Plan will only cover listed biosimilars for new patients starting on biologic drugs.  The program will initially include 10 medications, with new biosimilars to be added as they become available.  Existing patients are expected to transition to biosimilars by 30 April 2023.  The Ministry of Health reported that it expects the program to result in annual savings of $20 million once the transition is complete.  Saskatchewan is the fifth Canadian province to adopt a biosimilars switching program, following similar moves by British Columbia, New Brunswick, Quebec and Nova Scotia.

20 Oct 22 | UK | AbbVie acquires DJS Antibodies

AbbVie announced the acquisition of DJS Antibodies, a UK-based biotechnology company.  DJS’ lead program is DJS-002, a lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently under investigation for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases.

19 Oct 22 | FDA issues 17 observations for Lupin’s manufacturing facility

Lupin disclosed that the FDA has issued 17 observations in relation to its biotech manufacturing facility in Pune, India.  Lupin announced that it is committed to addressing the concerns raised by the FDA, and that it does not expect the observations to impact on the existing revenues raised through this facility.

19 Oct 22 | CA | Alvotech and JAMP expand exclusive partnership for CA

Alvotech announced that it has expanded its exclusive partnership with JAMP for Canada, adding AVT16 (immunology biosimilar) and AVT33 (oncology biosimilar) to their existing partnership.  Under the agreement, Alvotech will be responsible for the development and commercial supply of the products, in exchange for milestone payments and future sales royalties.  Alvotech and JAMP previously entered into a biosimilar commercialisation agreement for five biosimilar products in January 2020.

17 Oct 22 | JP | Fuji Pharma submits MAA for first biosimilar product

Alvotech announced that Fuji Pharma has submitted a marketing authorisation application to Japan’s Ministry of Health, Labor and Welfare for an undisclosed product.  This is the first MAA to be submitted under the exclusive partnership agreement between Alvotech and Fuji Pharma.  In February 2022, Alvotech and Fuji Pharma announced an expansion to their strategic partnership  for Japan.

17 Oct 2022 | JP | Biocon licenses two biosimilars to Yoshindo

Biocon Biologics announced that it will license its ustekinumab and denosumab biosimilars to Yoshindo for Japan.  Yoshindo will pay an upfront licence fee and further payments over the next few years as certain development milestones are achieved. Biocon estimates the market opportunity for the two biosimilars in Japan to be US$700m.

12 Oct 22 | US | Amgen releases 2022 Biosimilars Trends Report

Amgen published its 9th Biosimilars Trends Report, reporting on the current and future state of the US biosimilars market.  Among Amgen’s findings were the following:

  • Trends show an increase in savings per quarter, and in Q2 alone, savings in drug spend due to biosimilar availability are estimated to be $3.2 billion.
  • Biosimilars primarily covered under the medical benefit have typically launched at a wholesale acquisition cost (WAC) that is generally 10% to 57% lower than that of the reference product.
  • Seven or more launches of Humira® (adalimumab) biosimilars are possible in 2023. The entry of biosimilars is expected to lead to price declines across all products within the class.

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