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BioBlast® w/e 02 Sep 22: Teva’s skinny label case, Merck’s Keytruda® data, Outlook’s ophthalmic bevacizumab, Biocon FDA observations, Alvotech and STADA financial results, Fresenius Kabi’s Stimufend® FDA approved

by | Sep 5, 2022

Significant biosimilar activities this week include:

12 Aug 22 | US | Alvotech, Mylan & others file amicus curiae briefs in support of Teva’s skinny label case

Alvotech, Mylan, the Association for Accessible Medicines, and 42 professors of law, economics, business and medicine filed amicus curiae briefs in the US Supreme Court in support of Teva’s petition for a writ of certiorari.  Teva is seeking review of the controversial divided panel of the Court of Appeal for the Federal Circuit decision in August 2021 in which Teva was found to have induced infringement of a narrow GSK method of treatment (MOT) patent relating to the use of Coreg® (carvedilol) to treat congestive heart failure, despite Teva’s CHF indication carve out.  Teva and other companies have argued that this decision will threaten the future of ‘skinny-label’ for small molecules and large molecules.

25 Aug 22 | STADA publishes half year financial results

STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales.  Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million.  STADA currently markets five biosimilar products, including Hukyndra® (biosimilar adalimumab) and Oyavas® (biosimilar bevacizumab).

29 Aug 22 | Merck to present new Keytruda® (pembrolizumab) data at ESCO in September

Merck announced that it will present data on several oncology medicines at the European Society for Medical Oncology (ESCO) Congress in Paris from 9-13 September, including relating to KEYTRUDA® (pembrolizumab) and PADVEV® (enfortumab vedotin).

30 Aug 22 | US | Outlook Therapeutics resubmits BLA for ONS-5010 (ophthalmic bevacizumab)

Outlook Therapeutics announced that it has re-submitted its BLA for ONS-5010 LYTENAVA™ (bevacizumab-vikg, ophthalmic formulation) for wet AMD to the FDA.  Outlook first submitted its BLA in March 2022, however withdrew it in May 2022 following requests from the FDA for additional information.  Outlook reported that it has now provided the additional required information and is confident in the new application.

31 Aug 22 | US | FDA issues 17 observations for Biocon manufacturing facilities

Biocon announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab.  Biocon reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades.  Reportedly, Biocon does not expect the observations to impact current supply.

31 Aug 22 | Alvotech publishes financial results

Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe.  The company has $128.4Min cash/equivalents and has current borrowings of $120.8M.  Its R&D costs in the same period were 86.9M.

Alvotech “pipeline highlights” includes (amongst other things) an exclusive global licence agreement with BiosanaPharma regarding biosimilar omalizumab/to Xolair®, expanded partnership with Fuji Pharma, the completion and US submission of interchangeability studies for its high concentration adalimumab biosimilar, a US settlement with AbbVie relating to adalimumab and positive results from clinical studies on AVT04 (biosimilar ustekinumab/Stelara®).  Alvotech also secured funding of approximately $185M through the OACB merger and PIPE financing.

31 Aug 22 | Prestige Biopharma acquires more shares of Prestige Biologics

Prestige Biopharma announced that it will acquire more shares of Prestige Biologics, to secure a total of 24.88% of the CDMO company.  Prestige Biopharma reported that the new structure will allow the group to establish a full value chain with a 154,000 L, global-scale production facility.

01 Sep 22 | US | FDA approves Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim)

The FDA approved Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim).  Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

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