'Fastest way to biosimilar approval? As the CRO flies,' says industry group

By Dan Stanton contact

- Last updated on GMT

CROs used to develop majority of biosimilars says industry group

Related tags: Contract research organization, Biosimilars

Almost all of the biosimilars currently approved have been developed using a third-party research organisation according to a survey from the Association of Clinical Research Organizations (ACRO).

Results of the survey conducted among contract research organisations (CRO) belonging to the industry group found there is strong demand for third-party development services from pharma and biotech firms.

Members - including the top eight CROs based on revenue – were involved in the development of 85 of the 88 new drugs approved by US and EU regulators last year, but data from the survey supplied to this publication also demonstrates biopharma’s reliance on the CRO industry with 95% of biosimilars currently approved in Europe were worked upon by a third party.

The twenty biosimilars approved in the EU, along with the manufacturer and reference drug, are shown in the table below* but of this list just one, Silapo – a biosimilar of Amgen’s Epogen – did not make use of a CRO in its development.

Silapo is distributed by Cell Pharm and was developed by Germany-based Bioceuticals, a firm part-owned by Stada which in-licensed the biosimilar. Stada spokesperson Martina Moldenhauer confirmed to us that all R&D activity was done in-house at Bioceuticals, but as the firm licenses biosimilars, it has no strategy as to the development of such products.

Biosimilar

Company

Reference Product

Approval Date

Abseamed

Medice

Epogen (Amgen]

Aug 07

Bemfola

Finox Biotech

Gonal-f (Merck Serono)

Mar 14

Binocrit

Sandoz

Epogen (Amgen]

Apr 07

Biograstim

AbZ-Pharma

Neupogen (Amgen)

Sep 08

Epoetin alfa Hexal

Hexal

Epogen (Amgen]

Aug 08

Filgrastim Hexal

Hexal

Neupogen (Amgen)

Feb 09

Filgrastim ratiopharm

Ratiopharm

Neupogen (Amgen)

Sep 09

Grastofil

Apotex

Neupogen (Amgen)

Oct 13

Inflectra

Hospira

Remicade (Janssen)

Sep 13

Nivestim

Hospira

Neupogen (Amgen)

Jun 10

Omnitrope

Sandoz

Genotropin (Pfizer)

Apr 06

Ovaleap

Teva

Gonal-f (Merck Serono)

Sep 13

Ratiograstim

Ratiopharm

Neupogen (Amgen)

Sep 09

Remsima

Celltrion

Remicade (Janssen)

Sep 13

Retacrit

Hospira

Epogen (Amgen]

Dec 07

Silapo

Stada

Epogen (Amgen]

Dec 07

Somatropin Biopartners

Sandoz

Genotropin (Pfizer)

Jun 09

Tevagrastim

Teva

Neupogen (Amgen)

Sep 08

Valtropin

Biopartners

Humatrope (Eli Lilly)

Apr 06

Zarzio

Sandoz

Neupogen (Amgen)

Feb 09

As the biosimilar market becomes more lucrative, there are no signs that CROs are losing interest. inVentiv has signed biosimilar development deals recently with Oncobiologics​ and Proteomics​, while Parexel and PPD​ have both been vocal on the subject. Furthermore, according to early phase CRO Harlan Laboratories​ there is a growing demand from biotech and pharma firms for preclinical biosimilar services.

And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here​ for more details... 

*Since the survey was taken, two more biosimilars – Lilly’s insulin product Abasria, and Accord’s Accofil – have been approved but ACRO did not say whether third parties were used in their development.

Furthermore, ACRO’s survey did not include biosimilars approved solely in non-EU territories, including: CanMAB in India, EPO Kappa in Japan, Filgastrim (made by Teva and Sandoz) in Japan, Flammegis in CIS, and Herzuma in Korea.

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