BioBlast w/e 12 Aug 23

According to the Business Standard Biocon Biologics’ CEO has confirmed the transition of the North American part of Viatris’ global biosimilars business to Biocon will complete by the end of this quarter, less than a year after the companies signed a $3.34B acquisition of Viatris’ biosimilars business on 29 November 2022.  Biocon and Viatris have had a two-year transition services agreement in place following finalisation of the acquisition in November last year.  Biocon will also consider an IPO once Viatris is integrated.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.

Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary injunction order made by the Munich District Court on 4 August 2023.  The preliminary injunction prevents Amgen from supplying Bekemv®, its biosimilar to Alexion’s Soliris® (eculizumab), in Germany unless certain conditions are met, including a requirement that Amgen customers, including hospitals, agree not to use Bekemv® off-label.

On 19 April 2023, the EMA approved Bekemv® for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) (after the CHMP provided its positive opinion on 23 February 2023).  Alexion successfully applied to the Munich Regional Court for a preliminary injunction in May 2023, which was upheld by the 4 August 2023 District Court ruling.

The ODE rights expired in June 2019 for PNH.   However Alexion argued that there was a real risk that the biosimilar would be used off-label to treat other conditions over which Alexion still has exclusive rights.  The District Court noted that by sending letters of recommendation to medical practitioners, Amgen contributed to the risk of Bekemv®’s off-label use.

Alexion has also sued Samsung Bioepis in Germany over its eculizumab biosimilar Epysqli®, approved by the EMA on 30 May 2023, with a preliminary injunction hearing scheduled for 16 August 2023.

On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements Under BsUFA III’ seeking comment and suggestions by 10 October 2023.

The guidance provides recommendations for applicants and FDA review staff on six classification categories for original and resubmitted supplements to approved applications. The commitment letter associated with the Biosimilar User Fee Amendments of 2022 sets out these supplement classification categories and their associated review performance goals. The guidance intends to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing intervals (including intervals greater than 12 weeks) and that the safety of aflibercept 8mg remained consistent with the known safety profile of Eylea®.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

The UPC has appointed 21 new technically qualified judges (TQJs) across various areas, including chemistry and pharmaceutics, biotechnology, mechanical engineering, electricity and physics.  Following a selection process, the UPC Administrative Committee adopted the final list of recommended candidates on 2 June 2023.  Further appointments of TQJs are expected to take place later in 2023, with interviews to be scheduled in the upcoming weeks.

On 2 June 2023, Sanofi-Aventis filed revocation proceedings in UPC in relation to Amgen’s Repatha® (evolocumab), one of the earliest UPC revocation cases filed – only one day after the Court’s commencement.

News is my Business reported that the Puerto Rico Economic Development Bank (BDE) has approved US$3.85M in funding for Biosimilar Sciences PR LL and Ocyon Bio PR Inc. to facilitate the purchase of specialised biotechnology equipment. This funding comes from the US Treasury’s State Small Business Credit Initiative and represents BDE’s first partnership with a private financial entity, working alongside the Jesús Obrero Credit Union.  Biosimilar and OcyonBio are developing a biosimilar to AbbVie’s Humira® (adalimumab).

On 14 March 2022 OcyonBio and Biosimilar Solutions announced an agreement to create a contract biosimilars development/manufacturing organisation.

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  There were no proceedings on foot between the parties on foot in relation to FYB202 at the time of the settlement.

On 25 April 2023, Formycon announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 to Stelara®.   Formycon expects to file its BLA for FYB202 with the FDA later in 2023.

This settlement follows Johnson & Johnson’s previous settlement agreements with Amgen (for a licensed entry date no later than 1 January 2024), and with  Alvotech and Teva (for a licensed entry date for AVT04 in the US no later than 21 February 2025).

On 7 August 2023 Gingko Bioworks and Merck announced a collaboration to improve biologic manufacturing.  Gingko will “apply its expertise and capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterization and process optimization to improve” [Merck’s] “production efficiency and increase yield”.  Merck will pay Gingko up to US$490M under the deal, including research fees, milestone fees and license payments.

This is the second collaboration between the companies, which announced a biocatalysis project to improve Merck’s active pharmaceutical ingredient manufacturing in October 2022.

Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranizimuab), biosimilar to Genentech’s Lucentis®, has quadrupled to $26.7M since the last quarter.  It also reported that its net revenue has risen 81% compared to the previous quarter.  Yumisry®, Coherus’s biosimilar to AbbVie’s Humira® (adalimumab) was launched in the US on 3 July.