Endocrinology

Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.
Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).
While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.
Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.
The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.
Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.
A recently unsealed lawsuit alleges that drug maker Eli Lilly illegally worked with Healthstar Communications and VMS Biomarketing to provide free nursing services to induce healthcare providers to prescribe the drug maker’s insulin products Humalog and Humulin.
This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.
Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.
This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.


Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2018 Intellisphere, LLC. All Rights Reserved.