The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufacturers.

Teva says it remains hopeful that it can resolve US price-fixing allegations “in a positive way” with the US Department of Justice, but acknowledges that the matter could go all the way to trial.

Perrigo management provided colorful commentary on Perrigo’s latest endeavors to separate the company’s US generics business, following the recent sale of Perrigo’s Rosemont Pharmaceuticals subsidiary for an “attractive” multiple.

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

Teva and Alvotech have announced a major biosimilars alliance covering five products for the US market.

Fresenius Kabi is looking to make headway into biosimilars but saw its progress limited by COVID-19 in Q2. Management gave an update on the company’s endeavors during the Q2 earnings call, including key tender victories.

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

While the off-patent industry has welcomed concrete advice from the UK government over potential disruptions to medicines supplies when the country’s transition period with the EU expires on 31 December, concerns have been raised over the ability to build up safety stocks in the context of the COVID-19 pandemic, as well as a lack of clarity over the future regulatory landscape and pandemic-related procurement initiatives.

Paracetamol, opioids and non-steroidal anti-inflammatory drugs are among the common medicines that “can do more harm than good” and should not be used for managing chronic primary pain, according to a draft NICE guideline.

The World Health Organization has recently added further biosimilar versions of trastuzumab to its list of prequalified products, along with Roche’s original trastuzumab and rituximab brands, Herceptin and MabThera/Rituxan.

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

Perrigo management provided colorful commentary on Perrigo’s latest endeavors to separate the company’s US generics business, following the recent sale of Perrigo’s Rosemont Pharmaceuticals subsidiary for an “attractive” multiple.

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

After launching a biosimilar to Avastin (bevacizumab) in India, Cadila Pharma has now also launched rituximab and teriparatide biosimilars in its domestic market.

Teva and Alvotech have announced a major biosimilars alliance covering five products for the US market.

Eli Lilly has seen sales of its Basaglar insulin glargine hybrid remain static in the second quarter of 2020. However, the company reported total sales for the first half that were up by a tenth compared to the first half of 2019.

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Two weeks remain for companies to submit entries to the Global Generics & Biosimilars Awards 2020, with the entry deadline date of 14 August fast approaching ahead of the digital event on 3 November.