Biosimilars

Benefits of HTA implementation in the Middle East and North Africa

Health Technology Assessment (HTA) has become one of the most anticipated regulatory advancements across the Middle East and North Africa (MENA) due to its potential to modernize healthcare systems through innovative evaluation of healthcare interventions. Stakeholders see HTA as a tool to optimize healthcare resource allocation through transparent decision making.   The current state of […]

India: The emerging hub for biologics and biosimilars

The global pharmaceutical industry is facing a shift from chemical-based drugs to biologics and biosimilars. While small molecule therapeutics had previously dominated research and captured major market share, the advent of large molecule therapeutics (biologics and biosimilars) has rapidly transformed the pharmaceutical industry. Given their targeted mechanism of action and reduced toxicity, biologics have gained […]

How regulation, innovation, quality and access are inevitably intertwined

In a global industry like pharmaceuticals, the interdependencies among quality, access, innovation and regulation can have global implications. That message comes through clearly in the 2018 CPhI Annual Report, the compilation of expert forecasts and analyses that the organization puts together. The articles, with their focus on the future direction, technologies, opportunities and threats in […]

Algeria, Morocco and Tunisia changing their regulatory landscape?

Algeria, Morocco and Tunisia have fantastic potential for development in the pharmaceutical sector but weaknesses in some aspects of the pharma regulatory system create barriers to market access. Conscious of this, regulatory authorities in the region say they are determined to improve regulatory processes to allow faster access to market for essential and innovative medicines. […]

Changing product mix, shifting geography drive sourcing and manufacturing outlook

Manufacturing (supply) and sourcing (demand) are very much intertwined. In an industry where scaling up manufacturing or getting approvals to use a new supplier can take several months, if not years, it is critical to anticipate future needs. It is clear that one area to watch in biopharma sourcing and manufacturing is the changing product […]

Generics industry sets record for U.S. approvals, has ‘nothing to apologize for’

Download the full report. At the 2018 Association for Accessible Medicines (AAM) annual meeting, experts highlighted the generic industry’s recent accomplishments while noting that many challenges lie ahead. On the positive side for the industry, as noted by Jeff Watson, chairman, president and COO of Apotex, a controversial rule change regarding generic drug labeling in […]

Advances and challenges facing the biosimilars market

The majority of the 10 top-selling drugs in 2016 were biologicals, each exceeding sales of $5 billion. With increasing pressure to reduce healthcare costs, there is a need for cheaper biologicals and thus greater demand for biosimilars, biological drugs similar to the already approved biological. The first biosimilar was approved in the EU in April […]