Biopharmaceuticals: Approval Trends in 2007 - More than 70% of the products were produced in mammalian cells. - BioPharm International

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Biopharmaceuticals: Approval Trends in 2007
More than 70% of the products were produced in mammalian cells.


BioPharm International
Volume 21, Issue 10

PRODUCTS APPROVED




Abseamed (recombinant human erythropoietin alfa) is a recombinant form of human erythropoietin (EPO) produced in a Chinese hamster ovary (CHO) cell line. Native human EPO is a 165 amino acid, 36 kDa glycoprotein housing three N-linked and one O-linked glycosylation sites. It is synthesized almost exclusively in the kidney and is primarily responsible for stimulating and regulating erythropoiesis (red blood cell production). Abseamed is a biosimilar product, with Janssen-Cilag's erythropoietin Eprex/Erypo having served as reference medicine. The product is identical to both reference and native EPO in amino-acid sequence, but does differ in exact glycosylation detail. Compared to Eprex it displays somewhat higher sialylation levels, particularly associated with its O-linked glycan chain. The biosimilar product also displays higher levels of mannose-6-phosphate containing glycans associated with the Asn 24 N-linked glycosylation site. However, these specific glycans display only weak binding affinity for the mannose-6-phosphate receptor, and therefore are unlikely to trigger rapid product uptake from circulation.

Abseamed gained approval in the EU in August 2007. It is indicated for the treatment of anemia associated with chronic renal failure and for anemia accompanying chemotherapy of certain cancer types. It also can be used to reduce exposure of patients undergoing major orthopedic surgery to blood transfusions if transfusion related complications are anticipated.

The product is manufactured by batch cell culture in media supplemented with recombinant human insulin. After recovery from the cell media, the product is purified to homogeneity by a combination of standard chromatographic techniques. Downstream processing also incorporates a nanofiltration-based viral-removal step.

Glycine, sodium chloride, polysorbate 80, and phosphate buffer components are added as excipients, and the final product is filter sterilized, followed by aseptic filling into presterile syringes. The product is commercially available at two active ingredient concentrations, 16.8 μg/mL and 84 μg/mL, equating to 2,000 and 10,000 IU/mL, respectively.

The exact administration regime of Abseamed will depend on the indication being treated and will also be tailored to the individual patient. Product comparability to the reference medicine was established primarily by a double- blind, randomized, parallel group multicenter study involving 479 patients displaying anemia associated with chronic kidney disease. The primary endpoint measured was the mean absolute change in hemoglobin levels. A second study comparing the effects of Abseamed to Eprex in 114 cancer patients undergoing chemotherapy also was reported, with both studies confirming product comparability to Eprex. The most common adverse effect associated with product administration was an increase in blood pressure.

Abseamed's active ingredient is manufactured by Rentschler Biotechnologie GmbH (Laupheim, Germany). Germany-based Medice Arzneimittel Putter GmbH markets the product.

Binocrit. This product, along with its indications and all other characteristics, is identical to Abseamed. It differs only in the tradename used and in that Sandoz GmbH (Kundl, Austria), holds marketing authorization throughout the EU.

Cervarix (Papillomavirus, human, types 16,18) is a divalent vaccine containing the purified recombinant (C-terminally truncated) major caspid L1 proteins of human papillomavirus (HPV) types 16 and 18. The L1 proteins are produced separately using a recombinant baculovirus expression system coupled with an insect cell line derived from Trichoplusia ni. It is the first recombinant biopharmaceutical approved anywhere for human use that is produced using a baculovirus-based expression system. The product gained approval in the EU in September 2007 and is indicated for the prevention of cervical cancer and high-grade cervical intraepithelial neoplasia causally related to HPV types 16 and 18. High-grade cervical intraepithelial neoplasia refers to precancerous abnormal cervical cellular growth with a high probability of progression to cancer if left untreated. Over 100 genotypes of these double-stranded DNA-based enveloped viruses have been identified. Of these 100, 16 strains are regarded as highly oncogenic, with strains 16 and 18 believed responsible for over 70% of all cervical cancers.


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