Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

Biosimilars trade groups and manufacturers have expressed concern about what they say are “unnecessary hurdles” present in the US Food and Drug Administration’s (FDA) recent draft guidance on ...

The increasing demand from government agencies, insurers and patients to reduce the steep cost of blockbuster biopharmaceutical products has created considerable opportunities in the global biosimilar ...

Tailored EMA and FDA pathways may waive comparative efficacy studies when analytical and functional similarity are convincingly demonstrated, while preserving clinical confirmation for ...

In the United States, where around 8 million people rely on insulin for diabetes management, soaring prices have created barriers to accessibility. As Congress takes initial steps to cap monthly ...

A biosimilar drug manufacturer is concentrating on process optimization to increase uptake of its products in lower-income countries. According to Jeffrey Hausfeld, MD, chairman of the board of ...

After inking and expanding a biosimilar production partnership with Pfizer this summer, Korea’s Samsung Biologics is boosting yet another Big Pharma manufacturing agreement. Monday, Samsung said it ...

Providers and patients who want to understand biosimilars can now navigate through a new web app, that was created by Prime, and delivered in partnership with the AMCP Foundation and Biosimilars ...

Even if legislative hurdles are worked out, the U.S. market for biosimilars may not be the multibillion dollar market that many analysts have projected. But that doesn’t mean there won’t be robust ...

Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of ...