Market Access

The advent of biosimilar competition to Humira in the US in 2023 represents the largest loss-of-exclusivity opportunity ever for the off-patent industry. But with a host of biosimilar sponsors awaiting launches throughout the year, it remains to be seen how competition will play out.

President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Both providers and users of digital pathology are confident that clinical use cases and the evidence needed to assure payers and encourage investment by commercial labs will overcome challenges around access and adoption.

Big pharma appears to be resetting operations in India fueling some concerns of waning interest. In Vivo looks at what the realignment means or doesn’t.

Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?

Drug discovery services is one of the fastest growing areas of outsourcing because of pharma's increasing reliance on the companies operating within the field. This trend is causing increased interest from both pharma and PE-backed companies.

Biomedicine is a priority sector for Taiwan. The government has goals to establish Taiwan as the capital of biomedical research and development in the Asia-Pacific region. The country is striving to develop 20 new medicines, bring 80 high-value medical devices to market, and build biomedicine into a trillion-NT-dollar industry by 2025. Tax incentives and other credits will help expand the scale of the biotech and pharmaceutical industry.

With the fourth quarter just around the corner, China's closely-watched annual drug reimbursement and prices negotiations are entering a key final stage. But will applicants need to be more strategic than expedient?

Despite all of the buzz around adoption of digital health tools and whopping VC investments in consumer-facing digital health firms, pharma has yet to articulate a business model for co-development or integration of behavior-modifying digital therapeutics into their portfolios.

The US Supreme Court’s overturning of Roe v. Wade, which enshrined the right to an abortion in the Constitution for almost 50 years, could have consequences that extend beyond access to termination of pregnancy. 

The US Supreme Court has overturned Roe v. Wade, but numerous avenues could help to preserve access to abortion drug mifepristone – if legislators and lawmakers are willing to walk down them.