Generics

Tenofovir alafenamide fumarate raises targeting questions

In the race to bring generic drugs to market, Paragraph IV patent challenges are now an unavoidable fact of life. The question is no longer if there will be a patent challenge, but when and by whom. In the current hypercompetitive environment, no company can pursue all possible targets, so understanding the potential competitive landscape […]

Boost in Paragraph Four patent challenges drives competitive generics marketplace

Much attention has been given recently to the volume and pace of generic drug approvals by the FDA as that agency has prioritized increasing competition in the market to control costs.  Less attention has been given to the number of first-time Abbreviated New Drug Applications (ANDAs) and the outlook for competition in those generic drug […]

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 […]

Generics companies, responding to tough times, steer towards higher-risk portfolio strategies

These are tough times financially and strategically for many generics companies, particularly in the U.S., the world’s largest pharmaceutical market. Manufacturers are experiencing falling net prices driven by customer consolidation and increasing competition, coupled with a lack of operational flexibility and a landscape of new product opportunities significantly different from those of the past. Additionally, […]

Regulatory considerations, strategy and best practices for choosing a quality CMO

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and […]

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 […]

Modern tools to advance generic drug development and review

In news releases issued by the U.S. Food and Drug Administration (FDA), “firsts” always catch the eye. Because the majority of prescriptions in the U.S. are dispensed with generic medications, announcements of new “first generics” are especially noteworthy. These products are the first approval by the FDA that permits a manufacturer to market a generic […]

For the tradition-bound biopharma industry, resisting change is no longer an option

“For nearly half a century the pharmaceutical industry has lagged other industries in terms of productivity, efficiency and, some might argue, innovation,” wrote Bikash Chatterjee. “The excuse was that, as a regulated industry, any flexibility to implement improvements is limited, and compliance is of paramount importance.” Chatterjee, president and CSO of Pharmatech Associates, made these […]