At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.

Four of these are Celltrion biosimilars: Eydenzelt®/CT-P42 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®; Osenvelt®/CT-P41 (denosumab), biosimilar to Amgen’s Xgeva®; Stoboclo®/CT-P41 (denosumab), biosimilar to Amgen’s Prolia®; and Avtozma®/CT-P47 (tocilizumab), biosimilar to Roche’s Actemra®.

Biocon’s Yesintek® (ustekinumab), biosimilar to J&J’s Stelara® and CuraTeQ’s Zefylti® (filgrastim), biosimilar to Amgen’s Neupogen® were also given the green light by CHMP at its December 2024 meeting.

Eydenzelt® follows three aflibercept biosimilars already approved in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024) and Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024).  Formycon/Klinge’s FYB203/Baiama®/Ahzantive® received a CHMP positive opinion in November 2024.  Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

Sandoz’s Jubbonti® and Wyost® were the first denosumab biosimilars to be approved in Europe in May 2024.  The EMA has accepted MAAs for denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius Biotech/Organon (HLX14, May 2024).  In November 2024, CHMP adopted positive opinions for Samsung Bioepis’ Obodence™ and Xbryk™ (SB16).

The first tocilizumab biosimilar launched in Europe was Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023.  This was followed by the EU-approval of Biogen’s IV tocilizumab, Tofidence™, in June 2024.

Three ustekinumab biosimilars were launched during 2024, STADA/Alvotech’s Uzprovo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).  Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report.  The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.

The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules.  Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s Selarsdi^TM (Stelara®, ustekinumab); Accord Biopharma’s Hercessi^TM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s Yesafili^TM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).

Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.

The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label.  The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.

On 19 April 2024, Nora Pharma (subsidiary of Sunshine Biopharma) announced its entry into the biosimilars market with Health Canada’s approval of Niopeg® (peg-filgrastim), a biosimilar product comparable to Amgen’s NEULASTA®.

This follows Coherus’ launch of Udenyca Onbody® another biosimilar to Amgen’s NEULASTA® on 21 February 2024.

Peg-filgrastim was one of the first approved biosimilar molecules, and it is interesting to see new biosimilars approved 22 years after the first US approval in 2002.

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products.   The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023.  The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.

An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.  

On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.   

Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The withdrawal was made after guidance was received from EMA, which advised the Company it will not obtain EU-GMP certification of its biosimilars manufacturing facility within the current Day 180 clock stop period, which would not be extended.  CuraTeQ confirmed it will work with the EMA to re-submit the applications as soon as possible.

On 11 January 2022, Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe.

A study published in Health Affairs has suggested the US 340B Drug Pricing Program has reduced biosimilar uptake in hospitals that participate in the Program.  The 340B Program offers eligible safety-net hospitals (almost one third of US hospitals) to purchase originator medicines at a significant discount.  The authors analysed figures on filgrastim and infliximab and estimated that 340B program eligibility was associated with a 22.9% reduction in biosimilar adoption.

The research was sponsored by the Commonwealth Fund.

Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (biosimilar bevacizumab) in October 2022.

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar pegfilgrastim and bevacizumab are under FDA review, and Amneal plans to launch both products in 2022.

Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise.  This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.