Development

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.

Roman Drai, MD, PhD, deputy director and head of clinical operations at Geropharm, discussed Geropharm’s budding biosimilar pipeline and the company’s international pursuits during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence for biosimilars.

Interest in tocilizumab has grown lately as Roche has a clinical trial underway to evaluate efficacy in coronavirus disease 2019 (COVID-19)–related pneumonia.

Samsung Bioepis isn't flinching on its trastuzumab biosimilar launch schedule, COVID-19 and 4 other biosimilar competitors notwithstanding, said Sang-Jin Pak, MD, executive vice president of the company's Commercial Division.

With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.

Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).

The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.

Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.

The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.