Trastuzumab-DKST(Biocon)

Mumbai: Biocon is entering a transformative phase in its journey as a global biosimilars leader driven by regulatory shifts in the US, strategic partnerships and a robust insulin and GLP-1 portfolio, executive chairperson Kiran Mazumdar-Shaw said. The company is uniquely positioned to accelerate growth, reduce financial burden and expand its footprint in the high-value biologics space, Shaw told ET in an exclusive interview. "We are in a sweet spot and a very unique position," Shaw said. "Nobody else has interchangeable insulins and insulin now is becoming a very big opportunity for Biocon Biologics because of the fact that the actual insulin companies are planning to focus on GLP-1s. We are taking that advantage globally." Biocon is the only company with interchangeable biosimilar insulin analogues like insulin glargine (Semglee) and insulin aspart (Kirsty) in the US market. According to Shaw, the company's acquisition of Viatris' global portfolio of biosimilars, often scrutinised for its debt impact, has strengthened Biocon 's position as one of the top five biosimilars companies globally. Biocon Biologics acquired Viatris' global biosimilars business in 2022 for $3.3 billion and has been trying to cut acquisition-related debt of $1.2 billion. "People focus too much on the acquisition debt and not enough on the fact that we have become a leading global biosimilars company," said Mazumdar-Shaw. Referring to the company's R&D priorities in new therapeutic areas such as GLP-1 analogues , Mazumdar-Shaw said: "We have done this successfully for insulins and for liraglutide and are confident that semaglutide will be quite straightforward for us." According to Shaw, the recent draft guidelines by the USFDA, which propose to waive off the requirement for phase-III clinical trials for certain biosimilars that demonstrate robust chemistry, manufacturing and controls (CMC) package, presents a significant opportunity for Biocon . The USFDA's new draft guidance eliminates the need for most comparative efficacy trials-the costliest and slowest step in biosimilar development. Instead, it will allow developers to rely on advanced analytical and functional testing to demonstrate similarity with reference biologics. The agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. "Once we get the first approval without phase-III trials, it will set the stage for more launches and significantly reduce our R&D costs." It will allow the company to do more for the same amount of R&D spend, creating a compelling advantage over competitors, according to Mazumdar-Shaw. Biocon has already delivered an array of biosimilars over the past 12-18 months, including ustekinumab (Yesintek, used to treat chronic autoimmune condition), aflibercept (Yesafili, used for treatment of certain eye conditions), insulin aspart (Kirsty), bevacizumab (Jobevne, a cancer drug), and recently denosumab (Bosaya and Aukelso indicated for osteoporosis and cancer-related bone). The company has also reached a settlement with Amgen for denosumab, enabling its upcoming US launch. With these approvals, Biocon is in the "acceleration" phase, having built a diversified portfolio that few competitors, including Sandoz, Amgen, Pfizer , Celltrion, or Samsung, can match in scale and vertical integration, said Mazumdar-Shaw. "We have a large basket of biosimilars now in the market and nobody else has this scale of products," she said. Biocon's cancer drugs Fulphila (pegfilgrastim) and Ogivri (trastuzumab) have over 25% US market share. "The kind of growth story we are creating is going to be exciting in the immediate five-year window and beyond," said Mazumdar-Shaw. "After 2030, there will be some very exciting products becoming big-ticket opportunities for companies like us, more cancer drugs PD-1s and many other products." The insulin and GLP-1 segments are emerging as high-growth adjacencies for Biocon. Shaw emphasised that the company's deep experience in insulin manufacturing and patient familiarity with Biocon devices provide a natural advantage in GLP-1 analogues , so introducing GLP-1 is seamless. By Rica Bhattacharyya ,

“300块吃一年原研药”不是段子，印度药已经杀到我家门口。 医保刚出的价目表，直接把5000块的达格列净打成骨折，我算了下，一年省下的钱够给爸妈换台新空调，谁还愿意当冤种？ 别急着鼓掌。 上周我妈去县医院开药，医生悄悄把处方单往抽屉里一塞，换成印度Natco的帕博利珠单抗，报价只有原研的15%。 她听完没笑，反而回头问我：“便宜这么多，会不会是糖水？ ”我一时语塞，这问题像钉子，钉在所有患者心里。 我把近五年集采中标表翻了个底朝天，发现一个反常识的拐点：印度药企中标数从4个蹦到7个，靠的不是低价杀手锏，而是“附条件批准”的新通道。 简单说，只要他们的药在欧美日先上市，中国就绿灯放行，审批时间从两年缩到六个月。 规则一改，印度药不再走灰色水货，正大光明从海关拖车进来，税单齐全，发票正规，连药盒都印着中文不良反应。 苏州工业园里，Dr. Reddy’s的新厂刚投产，5亿片年产能听着像天文数字，折算下来每天130万片，机器一响，黄金万两。 他们雇了中国班长、印度工程师，两班倒，24小时连轴转，工资比隔壁电子厂高出一截。 工人私下说，老板敢给钱，就敢把片重误差压到±1%，比国内部分药企还狠。 质量卷到这个份上，低价只是顺水推舟，不是核心武器。 更狠的是Biocon的曲妥珠单抗生物类似药，7月拿到国家药监局盖章，定价直接砍60%。 注意，这是生物药，不是化学胶囊，技术门槛高到头皮发麻。 Biocon把细胞株、培养基、纯化工艺整套搬来中国，一边卖药，一边卖技术，顺手把冷链物流也打包上市。 别人降的是价格，他们降的是整条产业链的成本，本土药企看完脊背发凉：这还怎么玩？ 恒瑞、正大天晴们没坐以待毙，内部会议录音我听过一段，高管拍桌子：“研发投入再涨35%，不卷死就被卷死。 ”钱砸向两个方向，一是高难度仿制药，比如吸入剂、缓控释片，印度暂时追不上；二是创新剂型，把老药做成贴片、口溶膜，提高患者依从性，靠临床体验拉开差距。 一句话，正面拼价格拼不过，就绕到印度企业还没布局的赛道提前埋雷。 患者端的数据更赤裸。 达格列净用量一年翻三倍，不是医生突然爱上印度货，而是医保结算时，系统默认先跳低价。 除非患者主动拒绝，否则药房直接发印度版。 很多人第一次听说“默认勾选”竟发生在救命药上，心情复杂。 我表妹是内分泌护士，她告诉我，现在老病人复诊第一句话就是：“给我开那个300块的，别写错。 ”便宜成了最大的临床依从性，听着魔幻，却真实发生。 当然，裂缝也有。 部分三甲医院做稳定性试验，印度仿制药在高湿高温箱里放三个月，溶出曲线出现漂移，虽然仍在合格线内，但已靠近边缘。 医生担心批间差异，写病历时会加一句“建议定期复查肝肾功能”，留好退路。 监管也盯得紧，明年起印度药进口得额外提交长期疗效跟踪数据，等于把紧箍再勒一圈。 我把这些事捋完，最大的感受不是“狼来了”，而是“狼也怕人”。 印度药企拼命本土化，中国药企拼命国际化，两边在一条赛道对向狂奔，谁都不敢减速。 最终得利的是我们：药价被打下来，质量被抬上去，选择变多，钱包变厚。 至于担心？ 留给时间检验，毕竟疗效不是PPT，吃一年再看指标，身体不会说谎。