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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.”

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

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.

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.

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.

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.

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.

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

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.

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.

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.