Hikma’s licensing deal involves the first monoclonal antibody (mAb) biosimilar for oncology to be granted European marketing authorization, Truxima (rituximab). The company now has exclusive agreements with Celltrion for the marketing of three biosimilars – Truxima, Remsima (infliximab) and Herzuma (trastuzumab) – in the Middle East and North Africa (MENA) region. Hikma also announced in its 2017 annual report that it was reinforcing its ‘position as partner of choice in MENA through expanded partnership agreements with key partners’, which it says include Celltrion and Takeda.

Lupin announced on 8 March 2018 the signing of an agreement with the CSIR-NCL and the DST for conducting research on a continuous purification process development of a ‘similar biologic’ monoclonal antibody.

Existing manufacturing processes for mAbs are currently performed in batch mode, with overall process recovery limited to around 40−50%. Existing purification platforms for similar biologic mAbs involve integration of two to three offline controlled chromatography processes, which severely limits the throughput and yield of the target therapeutic product. In addition, manufacturers of similar biologics are also trying to match the purity profile of the originator biological. Therefore, any way of improving efficiency (and purity) by means of continuous manufacturing processes would increase the chances of approval and reduce costs. 

CSIR-NCL and Lupin have said that they will collaboratively work towards the development of a novel continuous purification process for manufacturing a similar biologic mAb. ‘This early research collaboration between industry and the CSIR institute is expected to yield rich dividends for the country,’ according to Professor Ashwini Kumar Nangia, Director of CSIR-NCL.

Lupin already markets three similar biologics in India – Bevacirel (bevacizumab), filgrastim and pegfilgrastim [1]. The company has also made an agreement with Australian biotech firm Neuclone to access cell-line technology to be used to develop biosimilars targeting cancer [2]. Lupin has also entered into a joint venture with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan [3].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related articles
Yoshindo and Lupin’s etanercept biosimilar completes trials

Hikma to acquire Boehringer’s US generics business

References
1. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2. GaBI Online - Generics and Biosimilars Initiative. Lupin and Neuclone biosimilars agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Neuclone-biosimilars-agreement
3. GaBI Online - Generics and Biosimilars Initiative. Lupin and Yoshindo start biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture

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