Merck gains US infliximab contract but drops insulin glargine biosimilar Posted 02/11/2018

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US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.

On 4 October 2018, Merck announced that its infliximab biosimilar, Renflexis, was determined to be the lowest priced infliximab option available and has therefore been awarded a national contract by the VA. The decision means that Renflexis will be the only infliximab product available on the VA National Formulary.

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

Renflexis (infliximab-abda) was approved by the US Food and Drug Administration (FDA) in April 2017 [1]. However, since its launch in July 2017, it has had a much lower uptake than its rival infliximab biosimilar, Inflectra, in the US market.

In contrast to this positive news, on 11 October 2018, it was made clear that Merck is pulling out of its deal with Samsung Bioepis (a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec) for insulin glargine biosimilar Lusduna.

The filing made by Samsung Bioepis in the Republic of Korea stated that Merck has terminated the development and commercialization agreement between the two companies for an insulin glargine biosimilar referencing Sanofi’s originator product Lantus (insulin glargine). The filing states that Merck will pay Samsung Bioepis a termination fee of US$155 million.

Merck made the deal with Samsung Bioepis to collaborate on an insulin glargine biosimilar back in 2013 [2]. Lusduna (SB9/MK‑1293) was approved in Europe in January 2017 [3] and received tentative approval from FDA in July 2017 [4].

Lusduna was approved via the FDA’s abbreviated 505(b)(2) pathway as a follow-on product and not as a biosimilar. No insulin glargine products were licensed under the Public Health Service Act at the time of filing, so there was no ‘reference product’ for a proposed biosimilar product.

Merck has, however, faced significant challenges in bringing Lusduna to the market in the US, including patent litigation from originator maker Sanofi. The company is not the only one to be having insulin troubles. Mylan and partner Biocon, are having similar troubles with their follow-on insulin glargine product (MYL‑1501D), which is already approved in Europe as Semglee [5]. The companies are also facing patent litigation from Sanofi and they also received a Complete Response Letter (CRL) from FDA.

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis
2. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilars of insulin glargine and teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilars-of-insulin-glargine-and-teriparatide
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
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 2018 Nov 2]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval

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Source: Merck, Samsung Bioepis

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