India-based biologicals specialist Biocon and US-based partner Mylan announced on 7 May 2019 that they have gained the global rights to the adalimumab biosimilar Hulio.
Mylan initially in-licensed Hulio from Fujifilm Kyowa Kirin Biologics for the European market, but this has now been extended to global markets.
Hulio (FKB327) was approved in Europe in September 2018 [1] following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation in July 2018 [2].
Under the terms of its global partnership with Mylan for monoclonal antibodies, Biocon says that it ‘retains its economic interest in this expanded in-licensing arrangement and will gain a share of profits from global markets’.
The pair are also separately developing an adalimumab biosimilar for the European and US markets, which is currently undergoing global phase III trials.
Biocon is India's leading biosimilars maker and the company has a strong biosimilars pipeline. Biocon, along with partner Mylan, gained US approval for their trastuzumab (Ogivri) and pegfilgrastim biosimilars (Fulphila) in 2017 and 2018, respectively [3, 4]. They also gained approval for their insulin glargine biosimilar in Europe and Australia in March 2018 [5].
In fact, many Indian companies are now targeting biosimilars. Another strong Indian player is Dr Reddy's Laboratories, which says that it is focusing on scaling up in its major markets, which include Russia, China, Brazil, South Africa and Ukraine. While Indian generics maker Lupin is also planning to supplement its traditional business in generics and specialty drugs with biosimilars for Japan, Europe and other markets by the end of the year, according to Lupin Biotech President Cyrus Karkaria. The company has already made a deal with Mylan for an etanercept biosimilar [6] and gained Japanese approval for its etanercept biosimilar YLB113 in March 2019 [7].
Related article
Mylan gains nod for Ogivri and launches Hulio in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-and-pegfilgrastim-biosimilars-Hulio-and-Udenyca
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-pegfilgrastim-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ogivri [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ogivri
4. GaBI Online - Generics and Biosimilars Initiative. FDA approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-pegfilgrastim-biosimilar-Fulphila
5. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval
6. GaBI Online - Generics and Biosimilars Initiative. Mylan and Lupin make deal for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 31]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar
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Source: Asia Nikkei, Biocon
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