3 Things In Biotech, June 1: Biosimilars Take Center Stage

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Welcome to another edition of “3 Things In Biotech You Should Learn Today,” a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Amgen’s biosimilar Herceptin is a go in Europe

Company: Amgen (AMGN)

Therapy: Biosimilar trastuzumab

Disease: Various

News: AMGN has received approval from the European Commission for their biosimilar form of trastuzumab (marketed by Roche (OTCQX:RHHBF) as Herceptin) for early-stage and metastatic HER2-positive breast cancer, as well as HER2-positive gastric cancer. The biosimilar will be marketed Kanjinti, and it beats me how they arrived at that name.

Looking forward: The biosimilar wave continues for RHHBF as AMGN gets another agent to market. Europe in particular has been pretty permissive with biosimilars, so I expect this trickle of approvals to turn into a relative flood of competition. This is great news for AMGN, since trastuzumab is still a very important agent in the management of breast and gastric cancer. I’m very interested to see how this ends up impacting RHHBFs bottom line.

Teva comes at the biosimilars from a different angle

Company: Teva Pharmaceutical Industries (TEVA)

Therapy: Biosimilar rituximab

Disease: Various

News: TEVAs South Korean partner in the development of all things biosimilar announced the resubmission of the application for their version of RHHBFs rituximab, CT-P10. This comes relatively shortly after the FDA rejected the application for this and Celltrions biosimilar trastuzumab back in April. This rejection was based on various issues flagged during inspection of the companys facilities, as opposed to clinical data.

Looking forward: Since the clinical findings for Celltrions various biosimilars show sufficient evidence of similarity in terms of the efficacy and safety, I expect that the FDA is relatively eager to get this approval done. However, manufacturing concerns should not be waved away very easily, particularly when were talking about complex biologics. Still, the resubmission of these applications puts us one step closer to increasing the competition for RHHBF even further.

Immutep provides a glimpse into its early-stage melanoma data

Company: Immutep (IMMP)

Therapy: Eftilagimod alpha

Disease: Melanoma

News: IMMP announced updated data from their combination study involving their LAG-3 antagonist eftilagimod and pembrolizumab in patients with advanced melanoma and suboptimal response to pembrolizumab. So far, 24 patients have been enrolled across three dosing cohorts, with an overall response rate of 61%. Two of the 18 evaluable patients achieved a complete response with the combination.

Looking forward: Considering the response rate for pembrolizumab alone in the original pivotal study was in the low 30% range, if these findings can be reproduced in a larger patient cohort, it could be a significant step forward for patients with melanoma. These response rates are even in the vicinity of the nivolumab-ipilimumab combo, which could present patients with a completely distinct set of immunotherapeutic options if they do not respond to one doublet. So this seems about as good as you’re going to see with phase 1 data!

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