Tag: Sandoz

Company News: Anergis Appoints Kim Simonsen as Chief Development Officer

– Senior Biotech Executive brings over 25 years of drug development expertise

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.

Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.

Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.

Food for Thought: The Future of Biosimilars

On June 8, the Society of Investment Professionals in Germany (DVFA) and its Life Science Committee hosted its annual conference which this time focused on biosimilars. The event covered key scientific topics, regulatory pathways and commercial issues of the market.

While experts agreed that the US will soon follow the EU in establishing a regulatory pathway for filing and approval of biosimilars – with a few originator companies still taking rearguard actions – it is not yet evident whether biosimilars will conquer the markets simply because of lower prices. In many EU countries, there will be no automatic substitution as with small molecule generics so that doctors need to be convinced to prescribe a particular “branded” biosimilar.

However, while the regulatory pathway is based on comparability, this claim cannot be made for marketing as Adem Koyuncu, Partner of Mayer Brown LLP explained. He said, it will constitute a case for litigation to claim that safety and side effect profiles of a biosimilar are the same as those of the originator product as these features have not been demonstrated to the same extend during the approval procedure. So the question for marketing is to educate practitioners and patients on biosimilars as an “alternative”, not as “substitute”. In fact, as Frank Pieters of Teva Pharmaceuticals said, it may be advisable, depending on the product and the environment, to develop hybrid marketing models, mixing “generic” and “branded” approaches.

Gertraud Unterrainer of ProBioGen explained the intricacies of developing cells lines for the production of biosimilars: the goal is to aim for the closest possible match to the originator product, not for a product that might be regarded as superior, e.g. in respect to the amount of impurities. She also stressed that activity assays are not a substitute for assessing the clinical impact of differences.

With all these details being tricky, both Falk Ehmann of the European Medicines Agency (EMEA) and Christopher Klein of Sandoz International do not expect imminent fierce competition from the many Asian and Indian companies developing biosimilars. “They can market their products in Europe,” Ehmann said, “however, they have to meet all our standards and requirements to get approval.”

Last but not least, Manfred Ruediger of LSP Life Science Partners said that as a VC, he is still refraining from investing in biosimilar companies as he still is not convinced on the investment multiples that can be reached with biosimilars within ten years time.

A link to the presentations will be available shortly here.