Foreword

Biosimilars

A new era in biotech

Expiring patents and changing regulations are paving the way for the growth of biosimilars.

Biosimilars

Succeeding in the market of the future

Translating the pharmacoeconomic potential of biosimilars into real improvements in access to expensive cuttingedge medicines remains a challenge that must be urgently addressed by healthcare authorities and policy makers.

Global Biogenerics Market

Opportunities and Challenges

The number of new biotechnology therapeutics makeup a significant proportion of all new drug development programmes. However, some of these new therapies are prohibitively expensive. Many toptier generic firms today have developed scientific and technological competencies to develop biogenerics, based on comparability guidances applicable to branded companies themselves.

Strategies for Biosimilar Development: Regulatory Framework and Technical Issues

The Current State of Play

Companies developing biosimilars face a challenge of adopting the right commercial and regulatory strategy, as the regulatory environment is not yet harmonized across the major markets. Draft guidelines for Japanese biosimilars were published by its regulatory agency in September 2008.

How Similar are Biosimilars in India?

A blind comparative study

It is important to show that biogeneric drugs are comparable in structure and function to that of the innovator and any differences have to be supported with data showing no influence on these parameters.

Strategy

Rethinking R&D

Novel approach to partnering

With a decrease in R&D productivity, increase in the cost of late-phase drug development and a greater competition for licensing opportunities, the stakes are high for the major players in the pharmaceutical industry.

Shaping the Future of Drug Development & Marketing Strategies

Payer perspectives

Two questions from patients about drug therapy-does it fix my problem? does it cause other problems?-suggest three new pharma strategies to address payers' priorities for improved results. These strategies are affected by payer perspectives as they shape the future of drug development and marketing strategies.

Twenty-first Century Crime

Counterfeit, illegally diverted and stolen pharmaceuticals

The rise in counterfeit medicines worldwide, with concomitant problems of toxicity, instability and ineffectiveness, is often underestimated. It is a hidden risk because counterfeit medicines are largely overlooked in the official public health statistics.

Personalised Genetic Diagnostics

Warrants global expansion

Direct-to-consumer genetic tests should be advertised as 'genomic art' to avoid the increase in general anxiety that they will introduce without including a properly informed healthcare provider.

Next Generation Pharmacovigilance

For enhanced patient safety

The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most costeffective healthcare intervention, they should bring about a significant transformation in their organisations to realise the glorious future.

Research and Development

Novel Genetic Vaccines

Rational design and standardised evaluation

Vaccines play a central role in health protection and advances in biotechnologies now offers numerous novel approaches for vaccine development. The goal of developing new vaccines to immunise people against infectious diseases has long been a key priority for the world's medical authorities.

Evaluating drug solubility in lipid-based delivery systems

Understanding the solubility behaviour of the drugexcipient complex in a lipid-based drug delivery system will help formulation scientists in rational selection of the appropriate excipients and in the determination of the optimum excipient levels to ensure drug remains solublised.

Can Genomics Provide

Blockbuster Drugs in Defiance of 'Personalised Medicine'?

It has become dogma that the era of genomics will require extensive genotyping of each patient 'personalised medicine', and that this will carve up the pharmaceutical marketplace, making blockbuster drugs a thing of the past. In the extreme, each patient will require their own unique, customdesigned drug. Put differently, every patient's disease will be an orphan disease. Let us use cancer genomics as an example, to refute this dogma.

Manufacturing

The Freeze Drying of Biologicals

Recent trends

Although conventional freeze drying in vials is still the predominant format, lyophilisation in alternative formats, such as pre-filled syringes, and alternate technologies such as spray freeze drying are becoming more popular.

Clinical Trials

Managing a Major eCTD Filing

An Amgen case study

This is a case study of how Amgen manages a major electronic Common Technical Document filing. It focusses on tools and processes developed and refined from 2005 to present. During this time, Amgen has filed three original Marketing Applications with an operational goal of submitting these simultaneously in four major regions (US, Canada, EU and Australia). Since operations groups exist in a fluid environment defined by evolving technology, it is important that these tools and processes adapt to meet the changing landscape of regulatory publishing.

Expert Talk

M&A and Partnerships in Pharma

Rising opportunities

Because R&D productivity is a problem for pharma the partnering opportunities are basically seen in licensing and acquisitions.

M&A and Partnerships in Pharma

Indian scenario

India's growing respect and legal / regulatory framework for IPR, favourable economic policies resulting into attractive investment destination and availability of huge talent pool for sustaining and growing operations is making India an attractive destination for multinationals now.

Information Technology

Regulatory Information Management

Leveraging standards and efficiencies of eCTDs

In managing Chemistry, Manufacturing and Controls documents, the larger process is involved for electronic regulatory submissions to health authorities. This is a case of an entire process standard providing significant gains in efficiency. A solution is needed for this area of the biopharmaceutical industry.