BioBlast w/e 15 Oct 23

Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.  The SB16 ph I and III studies demonstrate respectively pharmacokinetic bioequivalence and biosimilarity of SB17 to reference denosumab.

Merck announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

This will be the second indication for Keytruda® for the first-line treatment of such cancers in EU, following approval of Keytruda® in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy in August 2023.

Dr Reddy’s informed the Indian National Stock exchange on 12 October 2023 that the FDA issued a Form 483 with nine observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued after a product-specific pre-approval inspection of the facility by the FDA between 4 and 12 October 2023.

Prince Edward Island announced implementation of a biosimilar switching policy consistent with ten other provinces in Canada.  From 12 October 2023, patients covered under PEI Pharmacare program will begin switching biosimilars. Pharmacare beneficiaries will have until 30 June 2024 to work with healthcare providers to switch to a biosimilar.  Patients currently using Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade® or Rituxan® will be transitioned to a biosimilar version by 30 June 2024 to maintain their coverage.

We reported on previous Canadian announcements of Biosimilar switching initiatives, including Newfoundland and Labrador, Yukon, Ontario, British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facility in March 2023.  No other deficiencies were noted by the FDA.  Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly.  This will likely trigger a new BsUFA date for Alvotech’s ustekinumab.

In June 2023 Alvotech and Teva (the exclusive commercialization partner for AVT04 in the US), reached a settlement and license agreement with Johnson & Johnson that grants an entry date for AVT04 in the US no later than 21 February 2025.

On 25 September 2023 Alvotech received approval in Japan for AVT04.

Amneal Pharmaceuticals, Inc announced that it has added two denosumab products (biosimilars to Amgen’s Prolia^® and Xgeva^®) to its biosimilar pipeline.  The denosumab products are being developed by mAbxience.  MAbxience is responsibility for development and manufacture and Amneal is responsible for regulatory approval and has exclusive US commercialisation rights.

On 3 October 2022 Amneal Pharmaceuticals announced the US launch of another biosimilar developed by mAbxience: Alymsys® (biosimilar bevacizumab).

Samsung Bioepis presented new data on its SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) and Imraldi® (adalimumab, biosimilar to AbbVie’s Humira®) at the European Academy of Dermatology and Venereology (EADV) Congress.  The SB17 phIII study demonstrates that SB17 has equivalent efficacy and comparable safety and PK to Stelara® up to week 28 in patients with moderate to severe plaque psoriasis.  The Imraldi® four-year follow up study indicates that Imraldi can be started or transitioned from AbbVie’s Humira® (adalimumab) in patients with moderate-to-severe psoriasis.

On 11 September 2023, Sandoz and Samsung Bioepis entered an exclusive commercialisation agreement for SB17 in the US, Canada, EEA, Switzerland and the UK.

Samsung Bioepis released its third US Biosimilar Market Report.  The quarterly report details recent prices of all biosimilars based on Q4 2023 average sales price (ASPs) published by the Center of Medicare, Medicaid Services (CMS), and market share and price trends of all biosimilars.

The report explores three key influences on biosimilar utilisation:

1. Independent Medical Guidelines (noting that the influence of respected medical societies on biosimilar use ‘cannot be overstated’)
2. Duration of Treatment: Acute vs. Chronic Conditions (HCPs are often reluctant to initiate changes in chronic patients who respond well to the medicine)
3. Access and Rebate Walls (the impact of ‘grandfathering’ allows many patients to continue existing treatment even where biosimilars are available)

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that   biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023.

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its BLA for its insulin aspart (biosimilar to Novo Nordisk’s NovoLog®).  The letter did not identify any outstanding scientific issues with the product, but references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection of the Biocon Malaysia facility.

On 20 September 2023, Biocon’s Yesafili®,biosimilar to Regeneron’s Eylea® (aflibercept), received marketing approval from the European Commission.