CLINICAL TRIALS PROFILE FOR RETACRIT

All Clinical Trials for RETACRIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00843882 ↗	Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2009-01-29	This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
NCT03598582 ↗	Biological Predictive Factors of Response to ESA in Low Risk MDS Patients	Completed	Association pour la recherche sur les Affections Malignes en Immunologie Sanguine	Phase 4	2013-01-01	In this trial, the investigators would like to understand why a small percentage of patients will be refractory to ESA (independently of International prognostic scoring system (IPSS) and % of blasts). In a retrospective study of the "Groupe Francophone des Myélodysplasies (GFM)" , the investigators showed that about 43% of patients are refractory or will relapse after initial response to ESA and it has been shown that these patients have a poorer survival. The investigators plan to give a 12-week treatment of Epoetin alfa or zeta in low risk MDS patients and measure different biological factors to predict response to ESA: - evaluation by flow cytometry before and after treatment of the degree of dyserythropoiesis and dysgranulopoiesis which could explain the primary resistance or loss of response of a subset of patients, - screening by molecular biology of predictive factors of response to ESA, - Iron homeostasis will be measured via hepcidin, GDF-15 and ferritin levels.

Clinical Trial Conditions for RETACRIT

Condition Name

Condition Name for RETACRIT
Intervention	Trials
Myelodysplastic Syndromes	1
Previously Treated Myelodysplastic Syndrome	1
Anemia	1

Condition MeSH

Condition MeSH for RETACRIT
Intervention	Trials
Myelodysplastic Syndromes	2
Syndrome	2
Preleukemia	2

Clinical Trial Locations for RETACRIT

Trials by Country

Trials by Country for RETACRIT
Location	Trials
United States	42

Trials by US State

Trials by US State for RETACRIT
Location	Trials
Maryland	1
Kentucky	1
Kansas	1
Iowa	1
Indiana	1

Clinical Trial Progress for RETACRIT

Clinical Trial Phase

Clinical Trial Phase for RETACRIT
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for RETACRIT
Clinical Trial Phase	Trials
Active, not recruiting	1
Completed	1

Clinical Trial Sponsors for RETACRIT

Sponsor Name

Sponsor Name for RETACRIT
Sponsor	Trials
National Cancer Institute (NCI)	1
Association pour la recherche sur les Affections Malignes en Immunologie Sanguine	1

Sponsor Type

Sponsor Type for RETACRIT
Sponsor	Trials
NIH	1
Other	1

RETACRIT: Clinical Trials, Market Analysis, and Projections

Introduction to RETACRIT

RETACRIT, also known as epoetin alfa-epbx, is a biosimilar of the reference product epoetin alfa (Epogen/Procrit), used to treat anemia associated with chronic kidney disease (CKD) and chemotherapy-induced anemia. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

The clinical development program for RETACRIT included several key studies to establish its biosimilarity to the reference product.

Study EPOE-10-13

This study was a comparative efficacy and safety trial involving 320 adult subjects with CKD on hemodialysis. Participants were randomized to receive either RETACRIT or Epogen/Procrit subcutaneously for up to 16 weeks. The study found no clinically meaningful differences between the two treatments in terms of mean weekly hemoglobin (Hb) levels and the dose required to maintain target Hb levels[1][4].

Study EPOE-10-01

This study involved 612 adult subjects with CKD on hemodialysis and compared the intravenous administration of RETACRIT with Epogen/Procrit over 24 weeks. Similar to the previous study, it concluded that there were no significant differences in mean weekly Hb levels and the dosage required to maintain these levels between the two treatments[1][4].

Additional Studies

Other studies included patients receiving chemotherapy and those with anemia caused by kidney problems. These studies also demonstrated that RETACRIT was as effective as the reference product, Eprex/Erypo, in correcting and maintaining red blood cell counts[4].

Safety and Efficacy

The clinical trials for RETACRIT have consistently shown that it is safe and effective, with a comparable quality, safety, and efficacy profile to the reference product.

• Haemoglobin Levels: Studies have shown that RETACRIT maintains haemoglobin levels similar to those of the reference product, with levels around 11.4-11.6 g/dl during the treatment period[1][4].
• Dosage: The dose of epoetin required to maintain target Hb levels was similar between RETACRIT and the reference product[1][4].
• Transfusion Incidence: There were no statistically significant differences in the incidence of transfusions between the treatment groups[1].

Market Analysis

Current Market Share

RETACRIT has been gaining traction in the market since its approval. As of recent reports, the volume market share of epoetin alfa products shows that RETACRIT, along with the reference products Epogen and Procrit, continues to be a significant player.

• Volume Market Share: RETACRIT, along with Epogen and Procrit, maintains a combined share of approximately 70% in the epoetin alfa market[5].

Average Sales Price (ASP)

The ASP of RETACRIT has been competitive, contributing to its market share.

• ASP Trends: The ASP of RETACRIT has been trending lower compared to the reference products, making it an attractive option for cost-conscious healthcare systems[5].

Regulatory Environment

The approval and marketing authorization of RETACRIT have been facilitated by regulatory bodies such as the European Medicines Agency (EMA) and the U.S. FDA.

• EMA Approval: RETACRIT received marketing authorization from the EMA in 2007, validating its biosimilarity to the reference product Eprex/Erypo[4].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the biosimilar market, including RETACRIT.

• Increasing Outsourcing: Pharmaceutical companies are increasingly outsourcing clinical trials and development activities to Contract Research Organizations (CROs), which is expected to boost the biosimilar market[2].
• R&D Expenditure: Growing investments in research and development, particularly in biologics and biosimilars, are anticipated to propel market growth[2].
• Cost Savings: Biosimilars like RETACRIT offer significant cost savings compared to reference biologics, making them more appealing to healthcare systems[5].

Market Size and CAGR

The global pharmaceutical CRO market, which includes biosimilar development, is projected to grow significantly.

• Market Size: The global pharmaceutical CRO market is expected to reach USD 62.99 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.39% from 2025 to 2030[2].

Regional Dominance

The Asia Pacific region is expected to dominate the market due to the high number of actively functioning CROs and growing pharmaceutical industry.

• Regional Share: The Asia Pacific region held a revenue share of 46.40% in 2024, driven by the presence of numerous CROs in countries like China and Japan[2].

Key Takeaways

• Clinical Trials: RETACRIT has demonstrated biosimilarity to the reference product in multiple clinical trials, showing no clinically meaningful differences in efficacy and safety.
• Market Share: RETACRIT holds a significant share in the epoetin alfa market, competing effectively with the reference products.
• Regulatory Approval: RETACRIT has received marketing authorization from regulatory bodies like the EMA.
• Market Growth: The biosimilar market, including RETACRIT, is expected to grow driven by increasing outsourcing, R&D expenditure, and cost savings.

FAQs

What is RETACRIT used for?

RETACRIT is used to treat anemia associated with chronic kidney disease (CKD) and chemotherapy-induced anemia.

How does RETACRIT compare to the reference product?

RETACRIT has been shown to be as effective and safe as the reference product, epoetin alfa (Epogen/Procrit), in multiple clinical trials.

What is the current market share of RETACRIT?

RETACRIT, along with Epogen and Procrit, maintains a combined share of approximately 70% in the epoetin alfa market.

What are the key drivers of the biosimilar market growth?

Key drivers include increasing outsourcing to CROs, growing R&D expenditure, and the cost savings offered by biosimilars.

What is the projected market size of the pharmaceutical CRO market by 2030?

The global pharmaceutical CRO market is expected to reach USD 62.99 billion by 2030.

Which region is expected to dominate the biosimilar market?

The Asia Pacific region is expected to dominate the market due to the high number of actively functioning CROs and the growing pharmaceutical industry.

Sources

1. Pfizer for Professionals: RETACRIT® (epoetin alfa-epbx) Clinical Data | Safety Info.
2. GlobeNewswire: Pharmaceutical CRO Market Report 2025-2030.
3. FTC: Lessons for the United States: Biosimilar Market Development.
4. European Medicines Agency: Retacrit | European Medicines Agency (EMA).
5. Samsung Bioepis: Biosimilar Market Report - SAMSUNG BIOEPIS.

Last updated: 2025-01-04