Regulatory guidelines for biosimilars in Malaysia.

  title={Regulatory guidelines for biosimilars in Malaysia.},
  author={Arpah Abas},
  journal={Biologicals : journal of the International Association of Biological Standardization},
  volume={39 5},
The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even… CONTINUE READING

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Biogeneric regulatory policies in China and India: a comparison study

  • JW Guise, BM Carson
  • Drug Information Journal 2010;44:55e67
  • 2010
1 Excerpt

Biosimilar insulins : are they really ‘ similar ’ ?

  • Joshi
  • Supplement of JAPI February
  • 2010

Biosimilar epoetins erythropoietins, erythropoietic factors and erythropoiesis

  • H. Schellekens
  • 2009

Biosimilar insulins: are they really ‘similar’? Supplement of JAPI February 2009;57

  • Joshi
  • 2009
1 Excerpt

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