In an acquisition said by both US-based companies to be highly complementary, Azurity Pharmaceuticals has taken control of Slayback Pharma for an undisclosed fee.

Teva’s commercial interests in North America will soon be under new leadership after the firm announced that Sven Dethlefs would leave the company in mid-November. The firm has looked to the branded sector for his replacement.

Despite winning a landmark multi-billion-dollar antitrust suit earlier this year, Gilead Sciences has seen a US court give an initial green light allowing it to shell out nearly $250m to settle antitrust claims from direct purchasers of its two major HIV drugs.

Looking to take the FDA to court again, Vanda Pharmaceuticals has sued the agency for the way in which it evaluated and approved MSN Pharmaceuticals’ generic version of its sleep-wake disorder drug Hetlioz.

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

The FTC’s proposed consent order allowing Amgen to move ahead with its mammoth takeover of Horizon includes an interesting stipulation for industry – one involving biosimilars.

In an acquisition said by both US-based companies to be highly complementary, Azurity Pharmaceuticals has taken control of Slayback Pharma for an undisclosed fee.

Despite winning a landmark multi-billion-dollar antitrust suit earlier this year, Gilead Sciences has seen a US court give an initial green light allowing it to shell out nearly $250m to settle antitrust claims from direct purchasers of its two major HIV drugs.

While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).

In an acquisition said by both US-based companies to be highly complementary, Azurity Pharmaceuticals has taken control of Slayback Pharma for an undisclosed fee.

As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

Now in its tenth year, the Global Generics & Biosimilars Awards has received a record-breaking number of entries in 2023. Judges are now evaluating the nominees ahead of our awards ceremony on Wednesday 25 October at the Hotel Porta Fira in Barcelona.

In an acquisition said by both US-based companies to be highly complementary, Azurity Pharmaceuticals has taken control of Slayback Pharma for an undisclosed fee.

Teva’s commercial interests in North America will soon be under new leadership after the firm announced that Sven Dethlefs would leave the company in mid-November. The firm has looked to the branded sector for his replacement.

Despite winning a landmark multi-billion-dollar antitrust suit earlier this year, Gilead Sciences has seen a US court give an initial green light allowing it to shell out nearly $250m to settle antitrust claims from direct purchasers of its two major HIV drugs.

Looking to take the FDA to court again, Vanda Pharmaceuticals has sued the agency for the way in which it evaluated and approved MSN Pharmaceuticals’ generic version of its sleep-wake disorder drug Hetlioz.

As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.

Director of the FDA’s center for drugs slams firm for failing to reach out before suspending operations in the wake of an inspection that raised serious data integrity concerns. Instead, firms should be alerting the agency as soon as they realize there could be shortages.

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.