Credevo Articles |

Apr25 0

Biosimilar Planning: Strategies, Trial Design, And Regulatory Convergence

The global biosimilar market is undergoing a meaningful shift toward an “analytical-first” approach, making rigorous biosimilar planning more critical than ever. Regulatory agencies increasingly accept that comprehensive analytical characterization can establish biosimilarity without requiring large Phase III trials, though this is not yet universally applied across all molecule types. This evolution comes as more than […]

Apr15 0

Latest FDA Bioequivalence Guidelines 2025_Credevo

The pharmaceutical landscape from 2025 onwards will undergo a structural shift driven by the latest FDA bioequivalence guidelines (2025). These guidelines are aimed at tightening study expectations while streamlining regulatory pathways for generics. For generic developers, this evolving BE framework is not just a compliance update. Rather, the new BE framework fundamentally impacts formulation strategy, […]

Apr05 0

Xarelto (rivaroxaban) is a leading oral anticoagulant developed by Bayer and Janssen and accounts for about 45 percent of the direct oral anticoagulant (DOAC) market. It is widely prescribed for indications such as heart failure, thrombosis of the deep veins (DVT), lung embolism (PE), and postoperative prevention. As of 2026, the drug is at a […]

Mar25 0

The Briviact Generic Opportunity image Credevo

Brivaracetam, commercially available as Briviact®, is an established antiepileptic medication approved for focal epilepsy management. It is used in conjunction with other medications to help control seizures. This drug is designed to offer pharmacologic differentiation from levetiracetam, including higher SV2A affinity and improved tolerability in select patients. Major patents for Briviact® are set to expire […]

Mar15 0

Preparing for Post-Patent Generic Launch Credevo

When patents for Reference Listed Drugs (RLDs) expire, it opens the door for generic manufacturers to offer more affordable alternatives to brand-name drugs. However, successful entry into the market requires careful preparation ahead of the patent expiration. To demonstrate that a generic drug is equivalent to its branded counterpart, companies conduct thorough clinical research. This […]

Mar05 0

The pharmaceutical industry is undergoing a major change as patent exclusivity expires for popular drugs, highlighting vast generic drug opportunities. This shift will open up a $236 billion opportunity for generic and biosimilar manufacturers between 2025 and 2030. This significant loss of patent protection means more than just the end of exclusive rights. It will […]

Feb25 0

Choosing the right country for a clinical trial, particularly in complex therapeutic diseases, is a difficult task due to its reliance on factors that databases and standard metrics cannot fully measure. When therapies involve advanced technologies like modified immune cells or genetic interventions, the analysis must extend beyond basic feasibility. It requires examining site capabilities […]

Feb15 0

Shipping Tracking Devices for Use In Clinical Trials in Japan

Digital tracking devices play a pivotal role in modern clinical trials. They enable remote monitoring, enhance patient safety, and support continuous, real-time data capture. However, navigating Japan’s regulatory requirements for importing these devices can be complex and device-specific. Japan welcomes these advanced technologies, which are reshaping the design and execution of clinical trials. Therefore, it […]

Feb05 0

How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to […]

Jan25 0

Shipping Clinical Trial Materials to Japan through IOR/EOR

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others. Japan’s clinical trial regulations differ from […]

Biosimilar Planning: Strategies, Trial Design, & Regulatory Convergence

Latest FDA Bioequivalence Guidelines 2025: How the New Requirements Shape Your Generic Entry Strategy

Xarelto Generic Timeline: Understanding Patent Status, Pediatric Exclusivity, and Market Entry Windows

The Brivaracetam Generic Opportunity: Patent Status, Market Dynamics, and Bioequivalence Study Design

Preparing for Post-Patent Generic Launch: A Practical Guide to Bioequivalence Studies

Trending Molecules and Generic Drug Opportunities: Blockbuster Drugs With Upcoming Patent Expirations (2026–2030)

Choosing the Right Country for Your Clinical Trials in Complex Therapeutic Diseases: Why Investigator and Site Perspectives Count?

Shipping Tracking Devices for Use In Clinical Trials in Japan: Everything You Need to Know

How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them