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IGBA Favors WHO System Over Originator Database

 
• By Dave Wallace

In the final of three exclusive interviews, IGBA chair Jim Keon and secretary general Suzette Kox provide the latest update on global issues affecting the off-patent industries, including originator intellectual-property tactics in the form of the WIPO’s and IFPMA’s Pat-INFORMED database.

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The IGBA’s Secretary General And Chair Give Us The Latest On Global Issues Affecting The Generics And Biosimilars Industries • Source: Shutterstock

As the global industry association for generics and biosimilars companies, the International Generic and Biosimilar medicines Association (IGBA) is perfectly positioned to take an international view of the intellectual property landscape.

Recently, IGBA chair Jim Keon – who is also president of the Canadian Generic Pharmaceutical Association (CGPA) – and newly-appointed...

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Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

 
• By Urtė Fultinavičiūtė

The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

AstraZeneca Agrees Last-Minute $50m Settlement In Seroquel XR Delay Case

 
• By Dean Rudge

A class action suit alleging AstraZeneca delayed generic competition for Seroquel XR by making illegal agreements that stifled market entry for generic quetiapine competitors has been dismissed after the originator agreed to settle for tens of millions of dollars.

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• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
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Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
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Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By Dave Wallace

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).