Review of BMCP approved in the USA and EU

While in Russia the regulation of biomedical cell products (BMCP) area is at the stage of formation, abroad the market of such products is actively developing, and more drugs are coming into practical application. Thus, according to the US FDA, 17 BMCP have already been registered ( In the database of the European Agency for the Evaluation of Medicines, information on 16 BMCP can be found, 4 of which applications for registration were withdrawn. ( It’s worth noting that  additional safety monitoring is being carried out for nine drugs.  At the same time, only four drugs are registered in the USA and in the European Union and are intended for the treatment of oncological diseases (Yescarta, Kite Pharma, Incorporated; Imlygic, Amgen Inc.; Provenge, Dendreon Corporation; Kymriah, Novartis Pharmaceuticals Corporation)

  1. Biomedical cell products approved in the USA.

The U.S. Food and Drug Administration (FDA) has approved the use of BMCP for various medical applications. It should be taken into account the fact that in the United States cellular products are combined into one category with genotherapeutic, which, in fact, have no relation to human cells. A brief overview of certified preparations is given in the table below:

Trade name Manufacturer Active component Scope of application BMCP in Russia
1. Yescarta Kite Pharma, Incorporated Genetically modified T cells of the patient Oncology Yes
2. Imlygic Amgen Inc. Genetically modified oncolytic viral genetic material Oncology






3. Provenge Dendreon Corporation Autological mononuclear blood cells Oncology Yes
4. ALLOCORD SSM Cardinal Glennon Children’s Medical Center  








Hematopoietic cells, the precursor of umbilical cord blood























5. CLEVECORD Cleveland Cord Blood Center
6. DUCORD Duke University School of Medicine
7. HEMACORD New York Blood Center, Inc.
8. HPC, Cord Blood Clinimmune Labs, University of Colorado Cord Blood Bank
9. HPC, Cord Blood MD Anderson Cord Blood Bank
10. HPC, Cord Blood LifeSouth Community Blood Centers, Inc.
11. HPC, Cord Blood Bloodworks
12. GINTUIT Organogenesis Incorporated The culture of allogenic keratinocytes and fibroblasts in bovine collagen Surgery in oral cavity Yes
13. KYMRIAH Novartis Pharmaceuticals Corporation Genetically modified autologous T-cells Oncology


14. LAVIV Fibrocell Technologies, Inc. Authologic Fibroblasts


Dermatology Yes
15. LUXTURNA Spark Therapeutics, Inc. Genetic material in the composition of a viral particle Ophthalmology No
16. MACI Vericel Corporation Culture of autologous chondroicytes on porcine collagen membrane Orthopedics Yes
17. ZOLGENSMA AveXis, Inc. Genetic material in the composition of a viral particle Pediatrics (treatment of spinal muscular dystrophy) No


  1. Biomedical cell products approved in the EU countries.

If we talk about BMCP, which came into circulation in the EU countries, many of them are still under strict control, and some are completely withdrawn either after registration or during it (shown in blue in the table).  Another 32 products are used in EU hospitals as exceptions.

Trade name Manufacturer Active component Scope of application BMCP in Russia
1. HOLOCLAR Holostem Terapie Avanzate S.R.L Culture of epithelial cells of the corneal edge Ophthalmology Yes
2. Spherox CO.DON AG Spheroids of human autologous chondroicytes Orthopedics




3. Strimvelis GlaxoSmithKline Genetically modified autologous cells CD34 + Immunology Yes
4. Zalmoxis MolMed SpA Genetically Modified Allogenic T-Cells Oncology Yes
5. Maci


Vericel Corporation The culture of autologous chondroicytes Orthopedics Yes
6. Alofisel Takeda Pharma A/S Stem cells of adipose tissue of adult donors Gastroenterology Yes
7. Glybera uniQure biopharma B.V. Genetic material in the composition of a viral particle Gastroenterology No
8. Heparesc Cytonet GmbH KG Heterological cells of the human liver Pediatrics (treatment of hereditary diseases) Yes
9. Raligize


Advaxis Inc. Genetically modified cells Listeria monocytogenes Oncology No
10. OraNera


CellSeed Europe Ltd. Authological epithelial cells of the oral mucosa Ophthalmology Yes
11. Hyalograft C autograft


Anika Therapeutics S.r.l. Cells of cartilage tissue Orthopedics Yes
12. Cerepro Ark Therapeutics Genetically modified virus Oncology No

Unfortunately, many of the developed drugs completed their way quickly enough for various reasons. For example, Provenge, intended for the treatment of oncological diseases, could be stored only 18 hours under special conditions, and the cost of treatment when used was $93.000. As a result, these circumstances led to bankruptcy of the manufacturer. MACI, which entered the EU market in 2013 and is intended to restore the cartilage tissue of the knee joint, did not survive the transition period of the manufacturing company associated with the closure of the production site in Europe.

Thus, despite extensive developments in biotechnology and, in particular, BMCP, it is important to note that such preparations need support not only during the development phase, but also at “first steps” in the market.


  3. Eder C, Wild C. Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption. J Mark Access Health Policy. 2019; 7 (1): 1600939. Published 2019 Apr 19. doi: 10.1080/20016689 .2019.1600939


©Beawire – June 2019.