December 2015

Sandoz, a Novartis company and global leader in biosimilars, announced results from the PROTECT 2 study which compared the safety and efficacy of proposed biosimilar pegfilgrastim with the reference product, Neulasta®*. The study met its primary endpoints – showing it to be both equivalent and non-inferior to the reference product. Data was presented at the American Society of Hematology (ASH), Orlando, Florida.

Sandoz, a Novartis company and the global leader in biosimilars, announced  that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-α) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis - more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs) and approx 3.7 million Europeans with psoriasis.

Takeda Pharmaceutical Company Limited and Cour Pharmaceutical Development Company, Inc. announced a partnership to research and develop novel immune modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour’s Tolerizing Immune Modifying nanoParticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system.

Shri Ananth Kumar said that he is also pushing for the idea for a separate Ministry of Pharmaceutical and Medical Devices, so as to give a boost to the sector at the Annual Conference of Pharmaceuticals and Medical Devices in New Delhi. It plays important role in promotion, encouragement, enabling atmosphere and regulation in a good measure so that quality affordable drugs are available to the common masses of the country, as per minister.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) - India, Andhra Pradesh Regional Chapter head office at Raghavendra Institute of Pharmaceutical Education and Research – RIPER, in association with Indian Pharmaceutical Association (IPA) Anantapuramu Branch and Rural Development Trust (RDT) Hospitals Bathalapalli, Anantapuramu, Andhra Pradesh organized an One day “National Symposium on Exploring New Insights of Pharmacoeconomics and Outcome Research” on 5 December 2015 at RDT hospitals.