Forsteo ® (teriparatid)

För fullständig produktresumé för Forsteo® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Forsteo® (teriparatide): Definition av biosimilar

Biosimilarer är komplexa läkemedel som är liknande, men inte identiska, med godkända biologiska läkemedel.

Summary of Product Characteristics

Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.1

Forsteo was granted a marketing authorisation valid throughout the European Union  on 10 June 2003.1

Detailed Information

A brand company is not required to provide biosimilar companies access to proprietary manufacturing data resulting in a challenge to develop an identical product. Due to the difficulty associated with development, the industry shift to biosimilars occurred.2

Biosimilars are complex medicines that are similar, but not identical, to already-approved biologic medicines that are referred to as reference medicines. Biologic medicines are large, complex molecules derived from living cells.3

Biosimilars are designed to have no clinically meaningful difference compared with reference medicines.3

Biosimilars are not the same as generics, which are exact copies of small compounds produced through chemical synthesis.3

References

1. Forsteo [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Dranitsaris G, Amir E, Dorward K. Biosimilars of Biological Drug Therapies. Drugs. 2011;71(12):1527-1536. http://dx.doi.org/10.2165/11593730-000000000-00000.

3. Triplitt C, Hinnen D, Valentine V. How similar are biosimilars? What do clinicians need to know about biosimilar and follow-on insulins? Clin Diabetes. 2017;35(4):209-216. http://dx.doi.org/10.2337/cd16-0072

Datum fӧr senaste ӧversyn 2019 M08 07


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