Biosimilars

A follow-on biologic drug is not a ‘biogeneric’: Lessons from Omnitrope and Valtropin

Biosimilars/Research | Posted 08/03/2010

In an article by Dr Robert Roth and Dr Nicholas Fleischer of the Weinberg Group published in Journal of Generic Medicines of May 2009, it is stated that a follow-on biologic drug is not a ‘biogeneric’, based on lessons from Sandoz’s biosimilar human growth hormone Omnitrope (somatropin) and BioPartners’ Valtropin (somatropin).

PhRMA, Amgen correct NEJM article on biologics exclusivity

Biosimilars/Research | Posted 05/03/2010

In a NEJM Letter to the Editor of 18 February 2010, Mr David Wheadon, Senior Vice President of the Scientific & Regulatory Affairs team of the Pharmaceutical Research and Manufacturers of America 
(PhRMA) –having been employed by several pharmaceutical companies (Eli Lilly, GlaxoSmithKline, Abbott) and holding stock in Abbott Laboratories and GlaxoSmithKline– corrects the NEJM Perspective article by Mr Engelberg et al. of 12 November 2009, writing that “the record should be set straight” with regard to the market exclusivity of biologicals in the biosimilars debate.

FDA approves Amgen’s and Johnson & Johnson's the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs)

Biosimilars/News | Posted 05/03/2010

Amgen and Johnson & Johnson (J&J) announced on 16 February 2010 that the US FDA approved the companies' risk management strategy for patients with chemotherapy-induced anaemia who are receiving erythropoiesis-stimulating agents (ESAs), including Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and Johnson & Johnson's Procrit (epoetin alfa).

Improving effector functions of MAbs for cancer treatment: Enhancing antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)

Biosimilars/Research | Posted 04/03/2010

Mr Akito Natsume et al. of Kyowa Hakko Kirin, Machida-shi, Tokyo, Japan, have shown to improve effector functions of monoclonal antibodies (MAbs) for cancer treatment by enhancing ADCC and CDC, as published in their review article in Drug Design, Development and Therapy 2009:3 of December 2008.

Aglycosylated IgG mAbs can be engineered to display unique FcγR selectivity that mediate antibody dependent cell-mediated cytotoxicity

Biosimilars/News | Posted 04/03/2010

Until recently, bacterially derived monoclonal antibodies (mAbs) were unable to recruit innate immune cells and were thus ineffective at raising an attack against tumour cells. However, Mr George Georgiou et al. of the University of Texas, Austin, found that engineered mutations in the Fc domain can improve innate immune cell recognition by mAbs manufactured in bacteria, as published in the Proceedings of the National Academy of Sciences.

The study stems from efforts to make therapeutically useful mAbs in bacteria. A key roadblock is that bacterially manufactured antibodies lack Fc region glycosylation. “Antibodies that are not glycosylated cannot be recognised by immune cells,” said Mr Georgiou. In the article it is described how aglycosylated IgG variants expressed in bacteria that selectively bind FcγRI potentiate tumour cell killing by monocyte-dendritic cells. The authors explain that the N-linked glycan of immunoglobulin G (IgG) is indispensable for the interaction of the Fc domain with Fcγ receptors on effector cells and the clearance of target cells via antibody dependent cell-mediated cytotoxicity (ADCC). E.coli-expressed, aglycosylated Fc domains bind effector FcγRs poorly and cannot elicit ADCC.

US FDA prepares for biosimilars in 2011 budget plan, despite stalled healthcare reform bill

Biosimilars/News | Posted 03/03/2010

Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and Human Services (HHS) Secretary Ms Kathleen Sebelius says. In testimony before the House Energy and Commerce Committee on 4 February 2010, Ms Sebelius focused on funds included in the budget request for the FDA's efforts to improve medical product safety, including increased inspections and investment in tools to enhance the safety of increasingly complex drugs and biologics.

Bionomics of biosimilars - Indian options for investors

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

Bionomics of biosimilars – EU and US markets not easy for India

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market, she warns.

Bionomics of biosimilars – Indian opportunities

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

Bionomics of biosimilars – India’s next big cash cow?

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. According to her, however, players have many knots to untangle before they can have a firm grip over the economics of the market.