On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a Baltimore-based company, Lupin Pharmaceuticals.

Lupin is a subsidiary of the Indian company Lupin Limited. It is perhaps best known as a manufacturer of generic drugs, especially anti-infectives.

Why you may be hearing more about this company: At a January JP Morgan investor conference, Lupin announced its intention to bring a biosimilar application for etanercept to the European Medicines Agency in early 2019, with a 351(k) application filed with the Food and Drug Administration the following year. Additionally, Lupin has indicated that it will be jumping into the biosimilar market with both feet, with early-stage development beginning for six other medications: aflibercept, denosumab, filgrastim, pertuzumab, pegfilgrastim, and ranibizumab. It believes that the combined global market for these agents is $24 billion.

Lupin has not announced any marketing partnerships, meaning that they may decide to go it alone, unlike some of the major players (e.g., Allergan–Amgen, Celltrion–Pfizer, Samsung Bioepis–Merck, etc). With its extensive generic portfolio, Lupin may believe that it has the sales force necessary to effectively market in the biosimilar space as well.

In other news…Novartis has announced an unusual clinical trial move. In its clinical trial program for secukinumab (Costentyx^®), it has engaged in a head-to-head trial against both Humira^® and its own (i.e., Sandoz’s) biosimilar version of adalimumab (GP2017).  The head-to-head trial with GP2017 focuses on the ankylosing spondylitis indication, whereas the Humira comparative-effectiveness trial involves patients with psoriatic arthritis.