Development

The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.

A broader range of indications in rheumatology combined with a Canadian push for biosimilar acceptance bodes well for Merck's Brenzys product.

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

With anti–tumor necrosis factor (TNF) therapy showing promise in treating coronavirus disease 2019 (COVID-19), authors called for these agents to have a higher priority in research.

In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a phase 1 trial.

Bio-Thera said it has begun testing the safety its ustekinumab biosimilar in healthy volunteers.

The Australia-based biosimilar company hopes to compete with blockbuster programmed death-1 (PD-1) inhibitor franchises owned by Merck and Bristol Myers Squibb.

A look at efforts biosimilar manufacturers are taking to develop treatments for coronavirus disease 2019 (COVID-19).

Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.

From China to Taiwan, BeiGene and Bio-Thera Solutions hope to capture a large share of the bevacizumab biosimilar market.

Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.

The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.

There has been an outpouring of advocacy tugging biosimilars into the marketplace, and market share of these lower-cost drugs has increased.

Up-and-coming Henlius Biotech consolidates its footing in the biosimilar world with another regulatory approval.

Now that Polpharma Biologics has fully integrated Bioceros into its brand, the company hopes to become one of the world’s leading biologics manufacturers.

United States Pharmacopeia (USP), the FDA, and others deliver constructive critique on how India can bolster quality in its biopharmaceutical industry.

A new study showed that biosimilar interferon beta-1a (IFN-β-1a) may be effective in helping to treat patients with coronavirus disease 2019 (COVID-19).

Teva Pharmaceutical Industries has expanded on its hopes for a biosimilar comeback with a commercialization deal with Alvotech, which could bring as many as 5 biosimilars to the US market.

Amid the confusion of the pandemic, fundamental business strategies are reshaping the biosimilar playing field, according to corporate earnings reports.

Phase 3b trial results presented at American Academy of Dermatology Virtual Meeting Experience 2020 confirmed that Boehringer Ingelheim (BI)’s adalimumab biosimilar candidate is comparable to that of the reference product.

China-based Bio-Thera Solutions is breaking into the growing Russian biosimilar market by licensing the marketing rights for its unapproved golimumab biosimilar to Russian biopharmaceutical company Pharmapark.

Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

A recent opinion column outlines some principles to consider when thinking about changing the current US system of financing drug innovation, especially potentially curative therapies.

HLX14, a denosumab biosimilar targeted for the treatment of postmenopausal osteoporosis in patients with a high risk of fractures, was approved by China’s National Medical Products Administration (NMPA).

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.