Yenice Irem

Yenice Irem, Ph.D
Head of Biotechnology and R&D Director, Arven

Biography:
Irem Yenice graduated from Hacettepe University in 2007 with a Ph.D. degree in Pharmaceutical Technology. After working as a researcher at Hacettepe University, she joined Sanovel in 2007, a Turkish Pharmaceutical Generic Company of TOKSOZ Group. She has played leading roles in in the company’s biosimilar program. Over the last nine years, she set up the biotechnology division for biosimilars comprising manufacturing and characterization experts. In 2014, Dr. Yenice and her team moved to ARVEN, a company of TOKSOZ Group, with a vision to develop high-tech products committing to requested quality standarts toward global recognition. Dr. Yenice and her team developed the first biosimilar of Turkey, biosimilar filgrastim, from cell line to product. She has been working as the head of Biotechnology Department and R&D Director at Arven since December 2016.

Lecture:
Focus on Biosimilar Filgrastim Development

Biological medicines are made by or derived from a biological source, such as a bacterium, yeast or mammalian based cells. The active substances of biological medicines are larger and more complex than those of non-biological medicines. Development of biosimilars is much more challenging than generic small molecules due to their complexity of structure and manufacturing processes and their potential risks for increased immunogenicity. Therefore, specific regulatory approval pathways and guidelines must be followed during the development of biosimilars. Determination of the biosimilarity is based on the comparison of the candidate biosimilar product and its reference product with respect to structure (by using chromatographic, electrophoretic techniques , function (receptor binding and bioassay studies, etc), animal toxicity, human pharmacokinetics (PK) and pharmacodynamics (PD), clinical immunogenicity, and clinical safety and effectiveness. A rigorous scientific process for an evaluation of potential differences between candidate biosimilar product and its reference product is essential to ensure quality, safety and efficacy of the biosimilar. This presentation will focus on a Arven’s first biosimilar product (biosimilar filgrastim) and it’s development history. Detailed manufacturing processes, in-process controls, material and product testing, also structural and functional in vitro characterization studies including physical, chemical, biological tests, and comparative studies against the reference licensed drug product, will be presented. Non-clinical studies including in vitro and in vivo biological studies, and toxicokinetic study with biosimilar filgrastim, prior to initiating clinical development were carried out in accordance with related EMA guidelines.

References:
1. Similar biological medicinal products, CHMP/437/04 Rev. 1, 2015.
2. Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues), EMEA/CHMP/BMWP/31329/2005.

Yenice Irem, Ph.D., Yilmaz Emine, Uzgun Mehmet et al., Head of Biotechnology and R&D Director, Arven İlaç ve San. Tic. A.Ş., İstinye Mah. Balabandere Cad. No:14, 34460, Sarıyer, Istanbul