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Blockbuster biologicals in 2008 possible targets for new biosimilars? Posted 29/07/2009

With the recently introduced two US biosimilar bills and the expectation that a US biosimilars pathway will be realised before the end of this year, the race for biosimilar (or biobetter) versions of extremely expensive biologicals that will soon go off-patent has really begun.

Based on PipelineReview’s recent Top 20 Biologicals 2008 published on 9 March 2009, the following branded biotech medicines might be possible reference products for biosimilars in the near future:

1. Anti-tumour necrosis factor alpha recombinant monoclonal antibodies, with 2008 sales of US$16.36 billion (Euros 11.67 billion) based on the branded products Cimzia, Enbrel, Humira, Remicade.

2. Major cancer recombinant monoclonal antibodies, with 2008 sales of US$15.59 billion (Euros 11.12 billion) based on the branded products Avastin, Erbitux, Herceptin, Rituxan/MabThera, Vectibix.

3. Insulin and insulin analogues, with 2008 sales of US$10.90 billion (Euros 7.77 billion) based on the branded products Actrapid, Humalog, Humulin, Lantus, Levemir, Novolin, Novorapid.

4. Erythropoietins (epoetin alfa and epoetin beta), with 2008 sales of US$10.05 billion (Euros 7.16 billion) based on the branded products Aranesp, Dynepo, Epogen, ESPO, Neorecormon, Procrit Eprex, and the biosimilar Binocrit.

5. Interferon beta, with 2008 sales of US$5.35 billion (Euros 3.81 billion) based on the branded products Avonex, Betaferon/Betaseron, Rebif.

6. Granulocyte Colony-Stimulating Factor, with 2008 sales of US$5.18 billion (Euros 3.69 billion) based on the branded products GRAN, Neulasta, Neupogen, Neutrogin.

7. Recombinant coagulation factors (Factor VIIa, VIII, and IX), with 2008 sales of US$ 4.94 billion (Euros 3.52 billion) based on the branded products Advate, Benefix, Helixate, Kogenate, Novoseven, Recombinate, Refacto.

8. Enzyme Replacement Therapy, with 2008 sales of US$2.80 billion (Euros 1.99 billion) based on the branded products Aldurazyme, Cerezyme, Elaprase, Fabrazyme, Myozyme, Naglazyme, Replagal.

9. Human Growth Hormone, with 2008 sales of US$2.68 billion (Euros 1.91 billion) based on the branded products Genotropin, Humatrope, Norditropin, Nutropin, Saizen, Serostim and the biosimilar Omnitrope.

10. Interferon alpha, with 2008 sales of US$2.56 billion (Euros 1.82 billion) based on the branded products Intron A, Pegasys, Peg-Intron.

11. Ophthalmic antibody, with 2008 sales of US$1.76 billion (Euros 1.25 billion) based on the branded product Lucentis.

12. Antiviral recombinant huminised antibody fragment, with 2008 sales of US$1.23 billion (Euros 0.87 billion) based on the branded product Synagis.

13. Follicle Stimulating Hormone, with 2008 sales of US$1.16 billion (Euros 0.82 billion) based on the branded products Gonal-f, Puregon/Follistim.

It will be exciting to see who will come with the first cheaper (or possibly even better) versions of these (mega)blockbuster biologicals.

Source: PipelineReview La Merie Business Intelligence

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