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BioWorld - Thursday, March 19, 2026
Home » Topics » Drugs » Biosimilar

Biosimilar
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Prescription drug bottle, pills shaped in $ sign

More US-approved biologics translates to higher Rx drug spend

Feb. 14, 2022
By Mari Serebrov
Even as the U.S. Congress continues to kick the can down the road on prescription drug pricing, pressure to finally confront the issue is increasing. But as lawmakers debate price controls via direct Medicare negotiations vs. innovation, along with inflationary caps on price increases, one factor often gets downplayed: the role biologics are playing in the country’s overall spend on prescription drugs. While generics account for 90% of the drugs prescribed in the U.S., the other 10% of drugs prescribed account for more than 80% of the annual spending, according to the Association for Accessible Medicines.
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Biosimilars no priority in US FDA pandemic inspections

Feb. 9, 2022
By Mari Serebrov
Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
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FDA sign

Quick approval of ’UFAs needed to secure US FDA funding

Feb. 3, 2022
By Mari Serebrov
The process of reauthorizing critical U.S. FDA user fee agreements (UFAs) for drugs, generics and biosimilars took its first step forward in Congress Feb. 3 as the House Energy & Commerce Subcommittee on Health dipped its feet into the new enhancements included in the agreements the FDA negotiated with stakeholders over the past two years.
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USITC to investigate allegations of theft of Humira trade secrets

Jan. 27, 2022
By Mari Serebrov
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab).
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Connecting puzzle pieces

Amneal buys Saol’s baclofen portfolio in $83.5M deal

Jan. 5, 2022
By Richard Staines
Amneal Pharmaceuticals Inc. has bought a small portfolio of drugs from fellow U.S. biotech Saol Therapeutics Inc., adding the skeletal muscle relaxant baclofen to its portfolio and boosting its pipeline with a potential therapy to treat spasticity in a deal worth $83.5 million plus royalties.
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Abbvie U.S. headquarters

Abbvie attempts to fight off unlicensed Humira competition

Dec. 21, 2021
By Mari Serebrov
With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.
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Green approved stamp

Henlius bevacizumab biosimilar receives China marketing approval

Dec. 14, 2021
By Doris Yu
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA.
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Henlius bevacizumab biosimilar receives China marketing approval

Dec. 8, 2021
By Doris Yu
Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA. It was approved for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent, or metastatic non-squamous non-small-cell lung cancer.
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Tot Biopharm’s first ADC bevacizumab gets China lung cancer approval

Dec. 7, 2021
By Doris Yu
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
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Tot Biopharm’s first ADC bevacizumab gets China lung cancer approval

Dec. 2, 2021
By Doris Yu
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
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