Eye on Pharma: New Data, Clinical Developments, and Biosimilar Partnerships

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.

Phase 3 Data on Celltrion’s Tocilizumab Biosimilar

At the annual European Congress of Rheumatology (EULAR) 2024, Celltrion presented positive phase 3 data for CT-P47, a biosimilar candidate referencing Actemra (tocilizumab), in patients with moderate to severe rheumatoid arthritis (RA).¹

The study involved 471 patients who were randomized to receive either 8-mg doses of CT-P47 or reference tocilizumab every 4 weeks for 20 weeks. At week 24, patients on the reference product were rerandomized to continue with it or switch to CT-P47 until week 48.

The primary end point was the improvement in disease activity score 28 erythrocyte segmentation rate at weeks 12 and 24. The results showed equivalent efficacy between the 2 groups, with estimated score differences of –0.01 (95% CI, –0.26 to 0.24) at week 12 and –0.1 (95% CI, –0.30 to 0.10) at week 24, within the pre-defined equivalence margins. The treatment groups had similar mean serum concentration, incidence of treatment-emergent adverse events, and antidrug antibody positivity, demonstrating comparable pharmacokinetics, safety, and immunogenicity.

Additionally, a phase 1/3 study compared the pharmacokinetic (PK) similarity between the CT-P47 autoinjector (AI) and the pre-filled syringe (PFS) in healthy subjects, showing higher usability and similar PK profiles for the AI in patients with RA. No new safety signals were identified.

“The availability of tocilizumab biosimilars…represents a great opportunity to reduce treatment costs, contributing to health-care budget sustainability, improved patient access, and lower disease burden,” said Taehun Ha, vice president and Europe Division head at Celltrion.

Business Updates and New Partnerships

Two new partnerships in the biosimilar space were finalized. Alvotech and STADA Arzneimittel have chosen to expand their current partnership to include the development and commercialization of AVT03 (Uzpruvo), a denosumab biosimilar candidate.² The deal originally covered an adalimumab biosimilar and an ustekinumab biosimilar.

Under the agreement, Alvotech will develop and manufacture AVT03 in Reykjavik, while STADA will hold marketing authorization and have semi-exclusive commercial rights in Europe and exclusive rights in selected Central Asian and Middle Eastern countries. Additionally, STADA’s rights to the adalimumab and ustekinumab biosimilars will extend to Commonwealth of Independent States countries in Central Asia. Alvotech will regain commercial rights to AVT06, an aflibercept biosimilar.

Anil Okay, chief commercial officer of Alvotech, remarked, “We look forward to continuing to work with STADA on increasing patient availability of more affordable biologics in the denosumab market, as we have already done with our citrate-free, high-concentration biosimilar to Humira [reference adalimumab].”

STADA also formed a partnership with Bio-Thera Solutions regarding a golimumab biosimilar (BAT2506) candidate for the European Union (EU) and UK.³

Bio-Thera Solutions will develop, manufacture, and supply BAT2506, while STADA will have exclusive commercialization rights in the EU, UK, Switzerland, and selected countries. Bio-Thera will receive a $10 million upfront payment and up to $147.5 million in milestone payments.

Bryan Kim, head of global specialty at STADA commented, “With global sales in 2023 of US$2.2 billion, including more than US$1 billion outside of the US, golimumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars.”

Formycon Initiates Clinical Development of for Pembrolizumab Biosimilar

Formycon announced the start of the clinical development program for FYB206, a biosimilar for Keytruda (pembrolizumab), with the inclusion of the first patient.⁴

Pembrolizumab is a monoclonal antibody used to treat various tumors by blocking the PD-1/PD-L1 interaction, activating the body's antitumor immune response. Sales for Keytruda—the world's best-selling drug, with $25 billion in sales in 2023—are expected to grow due to rising cancer diagnoses.

The phase 1 study to compare the pharmacokinetics, safety, and tolerability of FYB206 with the reference product in patients with melanoma, designed in collaboration with the FDA and European Medicines Agency. A parallel Phase III study will compare FYB206's safety and efficacy with Keytruda in patients with non-small cell lung cancer. The company said it anticipates the earliest market entry for FYB206 after Keytruda's market exclusivity expires in 2029 for the US and 2030 for the EU.

“We are at the forefront of the development of a pembrolizumab biosimilar. Our FYB206 project not only has immense commercial potential, but above all offers exceptional therapeutic options. We are doing absolutely everything we can to ensure that more cancer patients worldwide can be treated with this drug in the future. After all, only biosimilars combine quality and efficacy with cost efficiency and thus improve healthcare,” emphasized Stefan Glombitza, PhD, CEO of Formycon.

References

1. Celltrion showcases promising results in phase III study for CT-P47, a biosimilar candidate of RoActemra^®(tocilizumab) in patients with rheumatoid arthritis (RA) at EULAR 2024. News release. Celltrion; June 14, 2024. Accessed June 26, 2024. https://www.celltrion.com/en-us/company/media-center/press-release/3264

2. Alvotech and STADA add to strategic alliance through denosumab partnership. News release. Alvotech; June 11, 2024. Accessed June 26, 2024. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-stada-add-strategic-alliance-through-denosumab/

3. Bio-Thera and STADA reach exclusive agreement for BAT2506, a proposed golimumab biosimilar, in the EU and UK. News release. Bio-Thera Solutions; May 28, 2024. Accessed June 26, 2024. https://www.prnewswire.com/news-releases/bio-thera-and-stada-reach-exclusive-agreement-for-bat2506-a-proposed-golimumab-biosimilar-in-the-eu-and-uk-302156882.html

4. Formycon starts clinical development program for FYB206,
a biosimilar candidate for immuno-oncology blockbuster drug Keytruda^®. News release. Formycon; June 13, 2024. Accessed June 26, 2024. https://www.formycon.com/en/blog/press-release/formycon-starts-clinical-development-program-for-fyb206-a-biosimilar-candidate-for-immuno-oncology-blockbuster-drug-keytruda/