Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives.

Teva has wrapped up an earlier deal with Sanofi that will see the French giant take command of its novel TL1A inhibitor currently in a Phase IIb study for ulcerative colitis and Crohn’s disease.

Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.

Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.

Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.

Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.

Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.

Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.

Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.

Partners Fresenius Kabi and Formycon have submitted a US filing for their FYB202 ustekinumab biosimilar rival to Stelara.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives.

Teva has announced a new investment from Royalty Pharma in its long-acting injectable formulation of olanzapine that is being developed for the US market with partner MedinCell.

Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels in early November. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.

At Medicines for Europe’s fifth annual value added medicines conference, the association announced that Pharmanovia CEO James Burt would take over as chair of its value added medicines sector group from Viatris executive Arun Narayan.

Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives.

Stada has struck a deal with CR Sanjiu for distribution and promotion of its cough and cold brands after identifying expansion in the Chinese market as a key strategic target.

Teva has wrapped up an earlier deal with Sanofi that will see the French giant take command of its novel TL1A inhibitor currently in a Phase IIb study for ulcerative colitis and Crohn’s disease.

Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.

Lupin has announced a number of drug approvals in the US, as well as a biosimilar partnership in the Middle East and the launch of a novel fixed-dose triple combination drug in its native Indian market.

Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost.

Partners Fresenius Kabi and Formycon have submitted a US filing for their FYB202 ustekinumab biosimilar rival to Stelara.

Generics Bulletin previews the most noteworthy and anticipated events for December 2023.

While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.

Samsung Bioepis has struck a US settlement with Johnson & Johnson that will allow partner Sandoz to launch the pair’s SB17 ustekinumab biosimilar to Stelara in early 2025, assuming FDA approval.

Glenmark hopes complex and respiratory products including a potential filing for generic Flovent pMDI can restore some lost sheen of its US business going forward, but a compliance comeback for its Monroe site may be pivotal to deliver material gains.

Running until 5 December, the Big Give campaign run by UK-based charity International Health Partners is once again doubling the value of donations, this year to support its child oncology programs in Malawi and Cameroon.