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Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.

Biosimilars Europe

Coronavirus Spotlight

Coronavirus Spotlight

WHO Urges Pfizer To Broaden Generic Paxlovid MPP Deal

As Pfizer’s Paxlovid joins the World Health Organization’s prequalification list, the organization has passed down several recommendations to the US-based Big Pharma, including expanding the scope of countries supplied under an MPP generic licensing agreement.

Coronavirus COVID-19 Generic Drugs

Interviews

Interviews

Samsung Bioepis ‘Setting A High Bar’ For Next Wave Of Biosimilars

In the wake of parent company Samsung Biologics completing its full acquisition of Samsung Bioepis, the Korea-based biosimilars player has told Generics Bulletin that it will be a “more robust company,” as it applies more rigorous standards to replenishing its pipeline of biosimilar candidates.

Biosimilars Companies

GGB Awards Return To Frankfurt In November

The Global Generics & Biosimilars Awards returns to Frankfurt this November, celebrating the greatest achievements across the generics, biosimilars and value added medicines industries. Entries are now open and you can book tickets to attend, both of which are free of charge.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

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Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.

Biosimilars Europe

Who’s Hired? Formycon Is Latest To Swap CEO

Formycon has become the latest firm to announce a new CEO, after similar moves at Orion and Strides. Meanwhile, Gedeon Richter has made management changes and a new director has joined Coherus.

Executive Changes Leadership

Goldman Ends Endo Coverage Following Q2 EBITDA Guide

One of the largest investment banks in the US has cancelled its coverage of Endo after the US-based firm revealed the extent of generic competition to its lucrative Vasostrict brand.

Commercial Companies

ANI ‘On The Cusp Of A Transformation’ Following Cortrophin Launch

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

Sales & Earnings Launches

Alembic Remains Upbeat Despite Rhizen Setback

Disappointment for Alembic-backed Rhizen after partner TG Therapeutics takes Ukoniq off the US market amid wider regulatory scrutiny around the PI3K inhibitor class of drugs. The Indian firm, however, remains upbeat about the US business, which saw significant growth in the fiscal fourth quarter and has 15-plus launches lined up.

Sales & Earnings India

Endo Buys Six Injectables Amid Shattering Decline In EBITDA Guidance

Endo maintains that it will continue to drive revenue and EBITDA growth via business development opportunities, after the advent of generic competition to its lucrative Vasostrict injectable led the firm to disclose potentially catastrophic Q2 profitability guidance.

M & A Deals
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Policy & Regulation Explore this Topic

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Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Biosimilars Regulation

UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage

Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.

Biosimilars Approvals

Biosimilars Forum Calls For Further Action On Biden’s Competition Order

Generics Bulletin sits down with Biosimilars Forum executive director Julie Reed to discuss preparing the HHS for Humira biosimilars, what more the agency could do for the industry and the Forum’s priorities over the next year.

Biosimilars Market Access

Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill

PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.

Generic Drugs User Fees

FDA Suggests ‘Institutional Resistance’ To Levothyroxine Generics Is Misplaced

Following the publication of a real-world case-study of levothyroxine use that included switching between different versions of the product, the FDA has suggested that “institutional resistance” to generics – including from American Thyroid Association guidance that warns against switching – “may not be supported by real-world evidence.”

Generic Drugs Regulation

Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill

Legislation in development also could create an option for tentative approval of interchangeable biosimilars.

Biosimilars Legislation
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Generic Drugs Explore this Topic

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ANI ‘On The Cusp Of A Transformation’ Following Cortrophin Launch

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

Sales & Earnings Launches

Germany’s Pro Generika Sees Steep Revlimid Savings

Generic lenalidomide competitors to BMS’ Revlimid brand have brought the cost of the cancer drug down by as much as 60% in Germany just a couple of months after launch, according to local generics association Pro Generika. However, the industry body has warned, price pressure must not grow so pronounced that the generics market becomes unsustainable.

Generic Drugs Pricing Strategies

Sun Outstrips Viatris’ Pentasa Action Date With First ANDA Approval

Sun Pharma has scooped a first ANDA approval for a rival to Takeda’s mesalamine-containing brand Pentasa, with Viatris making clear recently that it was eyeing a first-time generic launch for the gastrointestinal drug.

Approvals Generic Drugs
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Biosimilars Explore this Topic

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Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA

Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.

Biosimilars Europe

Viatris And Biocon Launch Bevacizumab Biosimilar In Canada

Viatris and Biocon have introduced their Abevmy biosimilar bevacizumab version of Avastin in Canada. Marking the third oncology biosimilar – and the fourth biosimilar overall – to be launched by Viatris in Canada, the product will face multiple other approved bevacizumab rivals in the market.

Biosimilars Launches

Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Biosimilars Regulation
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

ANI ‘On The Cusp Of A Transformation’ Following Cortrophin Launch

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

Sales & Earnings Launches

Accord Adds To Oncology Offering With Orgovyx

Accord Healthcare has struck a European licensing deal with Myovant Sciences for its Orgovyx (relugolix) treatment for advanced hormone-sensitive prostate cancer. The move comes shortly after sister company Accord Biopharma launched the Camcevi (leuprolide) prostate cancer treatment in the US.

Deals Strategy

Oral Humira Biosimilar Could Be A Game-Changer, Says Rani CEO

Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.

Biosimilars Value-Added Medicines
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