BioBlast w/e 07 Jul 23

Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license agreement with the USA-based BioFactura Inc, to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara® (ustekinumab).  Ustekinumab is a recombinant monoclonal antibody for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Under the terms of the agreement, CuraTeQ has exclusive license rights to commercialise BFI-751 in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ as well as in certain other markets, and the global manufacturing rights.  The product will be produced at CuraTeQ facilities in Hyderabad, India.  BioFactura has plans to begin a global Phase 3 trial of the product.  CuraTeQ intends to file the product in India and ‘emerging markets’ as early as 2024 and in the regulated markets beginning in 2026.

Biogen Canada announced that Quebec will reimburse patients receiving BYOOVIZ® (ranibizumab), biosimilar to Genentech’s Lucentis®, for certain retinal conditions such as age-related macular degeneration (AMD) in the presence of choroidal neovascularization, and visual deficiency caused by diabetic macular edema (DME).

BYOOVIZ® is the first biosimilar approved in Canada (on 2 March 2023) to treat neovascular (wet) AMD and DME.

Biogen and Eisai announced that the FDA has approved the supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb) to treat Alzheimer’s disease (AD).  On 9 June 2023, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of the use of LEQEMBI® for AD.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

Biocon Biologics announced it has completed the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.  This signifies completion of the first stage of implementation of the Biocon buy out, wherein Viatris’ biosimilar operations were fully transitioned to Biocon.

The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.  Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

Aurobindo Pharma announced that CuraTeQ Biologics’ BP02 showed equivalence to Genentech’s Herceptin® in its phase III clinical trial.  The study’s results indicated that BP02 has clinical response equivalence (pharmacokinetics and immunogenicity) and comparable safety profiles to the originator product.

On 26 June 2023, CuraTeQ Biologics withdrew its EMA MA applications for biosimilars ZEFYLTI® (filgrastim) and DYRUPEG® (pegfilgrastim) after receiving guidance from the EMA.

Samsung Biologics announced it has reached two agreements with Pfizer to manufacture its biosimilar products for oncology, inflammation and immunotherapy until 2029 in new South Korean Plant 4.

These announcements include a $704M contract and an additional $193M agreement (a follow-up to a $183M manufacturing deal previously announced on 2 March 2023).

Seven biosimilars to AbbVie’s Humira® (adalimumab): Coherus Biosciences’ Yusimry®, Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® are now commercially available in the US.

Each became authorised for supply in the US in July 2023 following their respective settlements with AbbVie. Samsung Bioepis settled with AbbVie on 5 April 2018, Viatris settled on 17 July 2018 (Biocon acquired Viatris’ global biosimilars business in November 2022), Sandoz settled on 11 October 2018, Fresenius settled on 18 October 2018, Boehringer settled on 14 May 2019, and Coherus settled on 27 November 2019, and Celltrion obtained a licence from AbbVie on 27 April 2022.

AbbVie entered into other deals with biosimilar entrants enabling US market entry, including: Alvotech (market entry on 1 July 2023, which has been delayed by a recent CRL from the FDA), Momenta (market entry on 20 November 2023), and Pfizer (market entry on 20 November 2023).

Kashiv Biosciences has completed a Phase I study comparing ADL-018, its omalizumab biosimilar, to Xolair® as marketed in the US by Genentech and in Europe by Novartis.  The study was a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study following single subcutaneous dosing in 306 healthy, adult subjects.

No results have been posted.

Amneal Pharmaceuticals and Kashiv Bioscience developed Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.