BioBlast® w/e 09 Sep 22: Lupin & I’rom’s denosumab, Lupin & DKSH to supply Alvotech products, Cipla/Alvotech’s AU biosimilar adalimumab approved, Formycon half year results, Celltrion’s tocilizumab IPRs instituted, Regeneron aflibercept studies, Organon’s AU biosimilars roadmap

by , | Sep 12, 2022

Significant biosimilar activities this week include:

25 Aug 22 | JP | Lupin and I’rom sign licence for denosumab in Japan

Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan.  Under the agreement, I’rom and Lupin will together conduct clinical trials and obtain registration, and I’rom will then exclusively distribute and market the product in Japan.

31 Aug 22 | US | PTAB institutes Celltrion’s two IPRs of Chugai/Roche tocilizumab patents

The PTAB instituted Celltrion’s two inter partes reviews (IPRs) of Chugai and Roche’s tocilizumab patents 8,580,264 and 10,874,677.  The IPRs were instituted on each of the grounds in Celltrion’s petition.

05 Sep 22 | US | Alvotech receives complete response letter from FDA for AVT02

Alvotech announced that it has received a complete response letter from the FDA in relation to its BLA for AVT02 (biosimilar adalimumab).  Alvotech anticipates being launch ready by the expected US launch date of 1 July 2023 .

06 Sep 22 | DE | Formycon publishes preliminary 2022 half year financial results

German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022.  Formycon reported a turnover of Euro 17.6 million in the first six months of 2022.  The preliminary report does not include the purchase price allocation effects from the ATHOS transaction reported in May 2022 under which Formycon acquired rights to FYB202 (biosimilar Stelara), 50% of the rights to FYB201 biosimilar Lucentis® and the operational development unit Bioeq GmbH.  Formycon has six biosimilars in development, and is also working on the development of a COVID-19 drug FYB207.

06 Sep 22 | AU | TGA approves Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02

Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hidradenitis suppurativa and uveitis.  Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019, which was expanded in March 2021 to include aflibercept, ustekinumab, denosumab and golimumab biosimilars.

07 Sep 22 | PH | Lupin and DKSH sign licensing and supply agreement for the Philippines

Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines.  The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.

07 Sep 22 | AU | Organon AU releases global biosimilars roadmap

Organon announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ setting out a number of priorities to achieve long-term sustainability of biosimilars in Australia, including:

  • Ensuring alignment of financial incentives that benefit all key stakeholders, including physicians, pharmacists and patients
  • Decreasing patient co-payments applied for biosimilars to enable cost savings not only for payers but for a broader range of stakeholders including patients
  • Increasing multi-disciplinary decision-making regarding dispensing of biosimilars to ensure the best outcomes for the patients and best value for the healthcare system.
  • Optimising existing pricing and reimbursement policy to mitigate the impact of erosion driven by mandatory discounts and considers the differences across therapeutic areas, the number of competitors and population size.

08 Sep 22 | Regeneron publishes results of aflibercept studies

Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and 16 week dosing regimes in diabetic macular edema and wet age-related macular degeneration.

09 Sep 22 | AstraZeneca publishes 5-year follow up results of bevacizumab

AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in newly diagnosed patients with advanced ovarian cancer. AstraZeneca reported that Olaparib with bevacizumab reduced the risk of death by 38% in HRD-positive patients compared to bevacizumab alone.

09 Sep 22 | US | FDA approves Rolvedon™(eflapegrastim)

Spectrum Pharmaceuticals announced that the FDA has approved its novel long-acting GCSF (LA-GCSF)ROLVEDON™ (eflapegrastim-xnst) 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.

10 Sep 22 | Merck presents new Keytruda® (pembrolizumab) data at ESCO in September

Merck reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11 September, including:

  • in patients with metastatic nonsquamous NSCLC, data from KEYNOTE-189 demonstrating KEYTRUDA plus pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) had a five-year overall survival (OS) rate of 19.4% versus 11.3% for chemotherapy alone; and
  • in patients with metastatic squamous NSCLC, results from KEYNOTE-407 showing the five-year OS rate for KEYTRUDA plus carboplatin-paclitaxel or nab-paclitaxel was 18.4% versus 9.7% for chemotherapy alone.

Separately, Eisai reported that would be presenting data on several trials on the combination of lenvatinib and pembrolizumab at the conference, including a late-breaking oral presentation of detailed results from the LEAP (Lenvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial as a first-line treatment for patients with unresectable hepatocellular carcinoma, as well as two mini-oral presentations with updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma, and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma.

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